advisory vs. Jollibee Padre Faura
whose address was 509 P. Faura St., Ermita, Manila and which was identified as owned and operated by Hobers Foods Corp. On April 7, 2010, no person at said restaurant inspected my luggage, which was large enough to contain deadly weapons. Also, an employee, identified as "Goldie", who accepted my food order, didn't have the required health certificate attached at the proper location on the clothing he/she was wearing. Also, there was no visible required sign of a senior citizens lane. I believe the Expanded Senior Citizens Act of 2003 was violated. The receipt issued by said Goldie was numbered 287959 and was dated 2010-04-07.

Chief - Mandaluyong Business Permits and Licensing Department will immediately inform SM Megamall's administration for them to impose corrective security measures
The above is based on a letter identified as from a "Catherine Jane DL Arce Chief City of Mandaluyong Business Permits and Licensing Department" addressed to Mr.
Victor E. Victoria Executive Secretary Mandaluyong City and dated March 25, 2010.

U.S. FDA 2010 Warning Letters
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/default.htm
Letter Issue Date Company Name Issuing Office Subject Close Out Date
April 20, 2010 Rainbow Acres Farm17 Philadelphia District Office PHS Act Violation Not Issued *
April 13, 2010 Mid South Produce Distributors, LLC18 Nashville District Office CGMP/Adulterated Not Issued *
April 13, 2010 Super Body Care19 Center for Drug Evaluation and Research Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
April 12, 2010 Hospira, Inc.20 Atlanta District Office CGMP for Finished Pharmaceuticals/Deviations/Adulterated Not Issued *
April 12, 2010 E-holistic Health /Hanna Cooper21 Center for Drug Evaluation and Research Unapproved/Uncleared/Unauthori zed Products Related to the H1N1 Flu Virus Not Issued *
April 09, 2010 Pfizer Inc.22 Center for Drug Evaluation and Research Sponsor Not Issued *
April 09, 2010 J & F International, Inc.23 Baltimore District Office Federal Food Drug and Cosmetic Act Violations, Compounded Drugs Not Issued *
April 08, 2010 Shamrock Medical Solutions Group LLC24 New England District Office CGMP for Finished Pharmaceuticals/Misbranded/Adulterated Not Issued *
April 08, 2010 Physician Therapeutics, LLC25 Los Angeles District Office New Drug/Labeling/Misbranded/Adulterated Not Issued *
April 08, 2010 Bryant Ranch Prepack Inc.26 Los Angeles District Office New Drug/Labeling/Misbranded/Adulterated Not Issued *
April 06, 2010 Aloha Medicinals Inc.27 San Francisco District Office New Animal Drug/Labeling/Misbranded/Adulterated Not Issued *
April 06, 2010 Pure Med Spa28 Center for Drug Evaluation and Research Lipodissolve/False & Misleading Claims/Misbranded Not Issued *
April 05, 2010 Monarch Med Spa29 Center for Drug Evaluation and Research Lipodissolve/False & Misleading Claims/Misbranded Not Issued *
April 05, 2010 Zipmed Mesoone30 Center for Drug Evaluation and Research Lipodissolve/False & Misleading Claims/Misbranded Not Issued *
April 05, 2010 7Seas LLC31 Florida District Office Dietary Supplement Regulations/Misbranded Not Issued *
April 05, 2010 Medical Cosmetic Enhancements32 Center for Drug Evaluation and Research Lipodissolve/False & Misleading Claims/Misbranded Not Issued *
April 05, 2010 All About You Medspa, LLC33 Center for Drug Evaluation and Research Lipodissolve/False & Misleading Claims/Misbranded Not Issued *
April 05, 2010 Innovative Directions in Health34 Center for Drug Evaluation and Research Lipdissolve/False & Misleading Claims/Misbranded Not Issued *
April 05, 2010 Spa 3535 Center for Drug Evaluation and Research Lipodissolve/False & Misleading Claims/Misbranded Not Issued *
April 02, 2010 Wright Place, LLC36 New England District Office Animal Sale for Slaughter as Food/Adulterated Not Issued *
April 01, 2010 Deitz, Robert, M.D.37 Center for Drug Evaluation and Research Clinical Investigator Not Issued *
March 31, 2010 Cut Fruit Express, Inc.38 Minneapolis District Office CGMP for Foods/HACCP/Adulterated Not Issued *

_____________________________________________________________________________________________________________________________________________________________________
FDA Obtains Consent Decree to Stop Marketing of Unapproved Sterilization System
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm209164.htm

FDA News Release

For Immediate Release: April 20, 2010
Media Inquiries: Dick Thompson, 301-796-7566; dick.thompson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Obtains Consent Decree to Stop Marketing of Unapproved Sterilization System
Steris agrees to stop selling SS1 tabletop system for endoscopes, other devices

The U.S. Food and Drug Administration today announced that a consent decree has been filed against the device manufacturer, STERIS Corp. of Mentor, Ohio. The decree stops the company from distributing unapproved and misbranded devices used to sterilize heat-sensitive instruments and medical devices. It prohibits the distribution of the STERIS System 1 Processor, or SS1, a tabletop liquid chemical system marketed to disinfect certain devices, such as endoscopes, that cannot withstand steam sterilization.

As part of the consent decree of permanent injunction, STERIS has developed a transition plan and rebate program for its U.S. customers to ease the transitioning to legally-marketed alternatives. The transition plan allows STERIS to continue to support existing customers who are using the SS1, but requires these customers to obtain a Certificate of Medical Necessity to get parts, components, accessories, and service during the transition period which ends on August 2, 2011.

“FDA’s oversight of medical devices helps ensure that patients are protected from unsafe or ineffective devices,” said Assistant Attorney General Tony West, who heads the Justice Department’s Civil Division. “When device manufacturers fail to comply with FDA’s regulations, they put patients at increased risk. As this consent decree shows, we will take whatever steps are necessary to make sure that all manufacturers are complying with FDA’s regulations.”

In May 2008, the FDA advised STERIS in a Warning Letter that significant changes made to the SS1 caused the device to be adulterated and misbranded. In December 2009, the FDA sent a letter to health care facilities and infection control practitioners advising them that the agency had not cleared the current version of the SS1. The letter recommended users transition to a legally-marketed alternative.

Under the consent decree, STERIS agreed to destroy used SS1 devices, components, parts, and accessories in the company’s possession within the United States by September 30, 2011. Some specified unused devices and component can, with FDA approval, be retained.

The decree was filed in the U.S. District Court, Northern District of Ohio on April 19, 2010, and is subject to court approval.

User facilities, including hospitals, are required to report suspected device-related deaths to the FDA and to the manufacturer, and serious injuries to the manufacturer or to FDA1.

In addition, healthcare professionals and consumers are encouraged to report serious adverse events that may be related to the use of unapproved and misbranded products to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

On April 5, 2010, the FDA cleared the STERIS System 1E (SS1E), which is an alternative to the SS1. The SS1E is a liquid chemical sterilant processing system. Liquid chemical sterilization is not equivalent to traditional sterilization (such as steam, ethylene oxide, and gamma irradiation). The SS1E can be used to process reusable heat-sensitive devices such as endoscopes and their accessories that cannot be processed using steam.











Travelers with Disabilities and Medical Conditions
http://www.tsa.gov/travelers/airtravel/specialneeds/index.shtm

Air Travel


TSA has established a program for screening of persons with disabilities and their associated equipment, mobility aids, and devices. Our program covers all
categories of disabilities (mobility, hearing, visual, and hidden). As part of that program, we established a coalition of over 70 disability-related groups and
organizations to help us understand the concerns of persons with disabilities and medical conditions. These groups have assisted TSA with integrating the unique needs
of persons with disabilities into our airport operations.

Since the initial total ban on liquids, gels and aerosols took effect on August 10, we have learned enough from the UK investigation to say with confidence that
small, travel size liquids are safe to bring through security checkpoints in limited numbers. We are confident in our increased security measures throughout the
airport. Therefore, passengers can purchase drinks in the secure boarding area and bring them aboard their flights.

TSA's checkpoint security screening procedures for persons with disabilities and medical conditions have not changed as a result of the current threat situation. All
disability-related equipment, aids, and devices continue to be allowed through security checkpoints once cleared through screening.

Additionally, we are continuing to permit prescription liquid medications and other liquids needed by persons with disabilities and medical conditions. This includes:

* All prescription and over-the-counter medications (liquids, gels, and aerosols) including petroleum jelly, eye drops, and saline solution for medical purposes;
* Liquids including water, juice, or liquid nutrition or gels for passengers with a disability or medical condition;
* Life-support and life-sustaining liquids such as bone marrow, blood products, and transplant organs;
* Items used to augment the body for medical or cosmetic reasons such as mastectomy products, prosthetic breasts, bras or shells containing gels, saline solution, or other liquids; and,
* Frozen items are allowed as long as they are frozen solid when presented for screening. If frozen items are partially melted, slushy, or have any liquid at the bottom of the container, they must meet 3-1-1 requirements.

However, if the liquid medications are in volumes larger than 3.4 ounces (100ml) each, they may not be placed in the quart-size bag and must be declared to the
Transportation Security Officer. A declaration can be made verbally, in writing, or by a person's companion, caregiver, interpreter, or family member.

Declared liquid medications and other liquids for disabilities and medical conditions must be kept separate from all other property submitted for x-ray screening.

For more information on these measures, please read our letter outlining this policy -- Changes in Allowances for Persons with Disabilities at Airport Security
Checkpoints (pdf, 101Kb)
http://www.tsa.gov/assets/pdf/special_needs_memo.pdf

Disability-related items permitted through the security checkpoint include:

* Wheelchairs
* Scooters
* Crutches
* Canes
* Walkers
* Prosthetic devices
* Casts
* Support braces
* Support appliances
* Service animals
* Baby apnea monitors
* Orthopedic shoes
* Exterior medical devices
* Assistive/adaptive equipment
* Augmentation devices
* Ostomy supplies
* CPAP machines & respirators

* Hearing aids
* Cochlear implants
* Tools for wheelchair disassembly/reassembly
* Personal supplemental oxygen
* CO2 personal oxygen concentrators
* Tools for prosthetic devices
* Medications and associated supplies
* Braille note takers
* Slate and stylus
* All diabetes related medication, equipment, and supplies
* Any other disability-related equipment and associated supplies

Please refer to the links below to assist you as you make travel preparations:
To learn about TSA's technology program to screen casts, prosthetic devices and braces, go to
http://www.tsa.gov/approach/tech/castscope.shtm

* Introduction
http://www.tsa.gov/travelers/airtravel/specialneeds/index.shtm

* Before You Go
http://www.tsa.gov/travelers/airtravel/specialneeds/before_you_go.shtm

* Tips For The Screening Process
http://www.tsa.gov/travelers/airtravel/specialneeds/editorial_1567.shtm

* Mobility Disabilities
http://www.tsa.gov/travelers/airtravel/specialneeds/editorial_1371.shtm

* Hearing Disabilities
http://www.tsa.gov/travelers/airtravel/specialneeds/editorial_1380.shtm

* Visual Disabilities
http://www.tsa.gov/travelers/airtravel/specialneeds/editorial_1373.shtm

* Hidden Disabilities
http://www.tsa.gov/travelers/airtravel/specialneeds/editorial_1374.shtm

o Pacemakers, Defibrillators, Other Implanted Medical Devices, & Metal Implants
http://www.tsa.gov/travelers/airtravel/specialneeds/editorial_1374.shtm#1

o Continuous Positive Airway Pressure (CPAP) Machine
http://www.tsa.gov/travelers/airtravel/specialneeds/cpap.shtm

o Medical Oxygen and Respiratory-Related Equipment
http://www.tsa.gov/travelers/airtravel/specialneeds/editorial_1374.shtm#2

o Diabetes
http://www.tsa.gov/travelers/airtravel/specialneeds/editorial_1374.shtm#3

o Medications
http://www.tsa.gov/travelers/airtravel/specialneeds/editorial_1374.shtm#4

* Assistive Devices and Mobility Aids
http://www.tsa.gov/travelers/airtravel/specialneeds/editorial_1370.shtm

o Prosthetic Devices, Casts, and Body Braces
http://www.tsa.gov/travelers/airtravel/specialneeds/editorial_1370.shtm#0

o Walkers, Crutches, and Canes
http://www.tsa.gov/travelers/airtravel/specialneeds/editorial_1370.shtm#1

o Augmentation Devices
http://www.tsa.gov/travelers/airtravel/specialneeds/editorial_1370.shtm#2

o Orthopedic Shoes, Support Appliances, and Exterior Medical Devices
http://www.tsa.gov/travelers/airtravel/specialneeds/editorial_1370.shtm#3

o Dressings
http://www.tsa.gov/travelers/airtravel/specialneeds/editorial_1370.shtm#4

* Service Animals
http://www.tsa.gov/travelers/airtravel/specialneeds/editorial_1572.shtm

* Children with Disabilities
http://www.tsa.gov/travelers/airtravel/specialneeds/editorial_1572.shtm

* Medical Conditions and Special Situations
o Military Severely Injured Program

Additional Resources

If you have additional concerns or questions you can also contact TSA's Contact Center.

E-mail - tsa-contactcenter@dhs.gov
Phone - 1-866-289-9673

For concerns about potential civil rights violations, you can contact TSA's Office of Civil Rights.

Toll-free - 1-877-336-4872
TTY - 800-877-8339
E-mail - tsa-contactcenter@dhs.gov

For information about overall air travel accessibility:

DOT Air Carrier Access Hotline

Toll-free - 1-800-778-4838
Internet - http://airconsumer.ost.dot.gov
___________________________________________________________________________________________________________________________________________________________
CPSC Approves New Flammability Standard for Mattresses
http://www.cpsc.gov/cpscpub/prerel/prhtml06/06091.html

Office of Information and Public Affairs Washington, DC 20207
FOR IMMEDIATE RELEASE
February 16, 2006
Release #06-091 CPSC Recall Hotline: (800) 638-2772
CPSC Media Contact: (301) 504-7908, Julie Vallese or Patty Davis


* Commissioner's Statements Attached

CPSC Approves New Flammability Standard for Mattresses
Federal standard could prevent 270 deaths each year

WASHINGTON, D.C. – One of the most important safety standards ever developed by the U.S. Consumer Product Safety Commission (CPSC) was approved today. By a vote of 3 to 0, CPSC approved a new federal standard to reduce the severity of mattress fires.

The new mandatory flammability standard for mattresses is the first major regulation passed by the CPSC in the agency's history. A major rule is one that has more than a $100 million annual impact on the economy.

When fully effective, CPSC estimates the new mandatory standard for mattresses is likely to save as many as 270 lives, preventing 78 percent of the deaths, and 1,330, or 84 percent of the injuries currently occurring every year.

"Consumers who purchase a new mattress that meets this standard will add an important layer of fire safety protection to their home," said CPSC Chairman Hal Stratton. "Lives will be saved as a result of this standard, as it requires new mattresses to limit the spread and intensity of a mattress fire, which will give people more time to escape from their residence."

The mandatory standard addresses mattress fires ignited by open flame sources, including matches, candles, lighters, and other related scenarios. The test protocol was developed in coordination with the National Institute of Standards and Technology (NIST). "NIST's contribution to CPSC's development of this standard was invaluable," said Stratton.

Under the new mandatory federal rule, mattress sets must meet a performance standard. The CPSC does not specify how manufacturers are to design their mattresses to meet the standard. The new federal standard for mattresses goes into effect on July 1, 2007.

In the performance standard, the peak heat release rate is limited to 200 kW during a 30 minute test. The total heat release is limited to 15 MJ within the first 10 minutes of the test.

Cigarette ignition is covered by a separate mandatory standard. That standard, 16 CFR Part 1632, has been in place for more than 30 years during which deaths and injuries from mattress fires caused by smoking materials have fallen dramatically.

Picture of Mattresses During Ignition Test
Three minutes after a conventional mattress is ignited during testing. Three minutes after a mattress that complies with the new federal mattress standard is ignited during testing.

movie iconConsumers can also view a video clip showing side by side ignition testing of conventional and complying mattresses (standard version or a higher quality version - broadband connection recommended) (transcript). This is in "streaming video" format.

sound icon U.S. Consumer Product Safety Commission (CPSC) Chairman Hal Stratton sound bites from the Commission Meeting on the Final Rule and Preamble for the Flammability (Open Flame) of Mattress Sets held on February 16, 2006. (transcript)

sound icon CPSC Chairman Hal Stratton sound bites from the Press Conference after the Commission Meeting on the Final Rule and Preamble for the Flammability (Open Flame) of Mattress Sets held on February 16, 2006. (transcript)





STATEMENT OF THE HONORABLE HAL STRATTON, CHAIRMAN, AND THE HONORABLE NANCY NORD, VICE CHAIRMAN,
ON THE FINAL RULE AND PREAMBLE FOR THE FLAMMABILITY (OPEN-FLAME) OF MATTRESS SETS
February 16, 2006

Today's approval of the Standard for the Open Flame Flammability of Mattresses and Mattress/Foundation Sets is a landmark for the Commission: it holds tremendous promise for saving lives and preventing injuries and property destruction and exemplifies the government-private sector partnership Congress envisioned for this agency.

The rule which we have put in place is the culmination of careful thought and hard work by Commission Staff and by private and public-sector stakeholders. But most of all, it was fused by the commitment to improve the safety of the American consumer.

On the one hand, the Rule has the virtue of flexibility: manufacturers are required to meet performance standards and thus have considerable flexibility in choosing among a range of component materials. Consumers thereby also benefit by continuing to enjoy a broad range of choices for comfort, price and aesthetic preference. On the other hand, the Rule is stringent and significantly raises the basic level of safety that all mattresses must meet. We anticipate approximate averages of 270 lives and 1,330 injuries will be prevented annually. That is a significant achievement.

As members of the Consumer Product Safety Commission, we are dedicated to continuing work in this "can-do" spirit to wisely and successfully address safety challenges presented by product performance, market place developments and consumer expectation.


STATEMENT OF THE HONORABLE THOMAS H. MOORE
ON THE FINAL RULE AND PREAMBLE FOR THE FLAMMABILITY (OPEN-FLAME) OF MATTRESS SETS
February 16, 2006

The new open flame mattress flammability standard represents a significant improvement in fire protection for consumers. It is anticipated that between 240 and 270 deaths will be prevented and that another 1150 to 1330 people will escape injury each year from fires due to mattress ignition once this standard is implemented. The National Institute of Science and Technology and the mattress industry were instrumental in making this new standard possible. I would be remiss if I did not also acknowledge the work done in this field by the State of California's Bureau of Home Furnishings and Thermal Insulation. States are often pioneers in consumer protection, providing the impetus for new or improved federal regulation and California is usually in the forefront on consumer issues.

Much will be said about the benefits of this new federal flammability standard. I would prefer to devote my entire statement to those benefits, but unfortunately there are other issues in this rulemaking proceeding that require comment. Since the issuance of Executive Order 12988 in 1996, the Commission has routinely inserted into the Preamble of any new regulation, the specific preemption provisions that apply to that regulation as stated in the authorizing statute. No commentary has accompanied the statement of the preemption provisions and, with one exception, the Commission has never expressed a view about their scope in a Preamble1. The proposed Preamble language in this Final Rule is a departure from Commission precedent and, in my opinion, errs on several important points. It errs when it makes the sweeping statement that in the absence of an exemption, "the federal standard will preempt all non-identical state requirements." It errs when it concludes that the preemption provisions preempt inconsistent "court created requirements." And it errs when it implies that the Executive Order requires the Commission to draw any such conclusions.


Non-identical Federal or State Flammability Standards

Non-identical Federal or State flammability standards can and do exist without an exemption from the Commission. Section 16 (b) of the Flammable Fabrics Act (FFA) allows the Federal Government, and the government of any State or political subdivision of a State, to establish a flammability standard "for its own use" that establishes a higher degree of protection from the risk or occurrence of fire than has been established under the Act. The legislative history gives certain examples of what "for its own use" means, such as for a State hospital, institution or old age facility. In some cases it is this language that has allowed most states to adopt stricter fire standards for mattresses used in high risk occupancies, such as prisons, dormitories, and nursing care facilities than the current federal cigarette ignition mattress standard. The intention of the new mattress open-flame standard, as stated in the Preamble on pages 14 and 37, is to cover the same mattresses that the existing cigarette ignition mattress standard covers. I take from that, that state standards for high risk occupancies, for example, are in no more danger from preemption under this standard than they were under the cigarette standard, which appears to have had little or no affect on them.


Non-identical State Court Rulings

The next issue is the statement in the Preamble that the preemption provisions in the Flammable Fabrics Act encompass non-identical state court rulings. The starting point of any analysis must be the statutory preemption language itself. Subsection (a) of section 16 lays out the basic preemption provision:

"(a) Except as provided in subsections (b) and (c), whenever a flammability standard or other regulation for a fabric, related material, or product is in effect under this Act, no State or political subdivision of a State may establish or continue in effect a flammability standard or other regulation for such fabric, related material, or product if the same standard or other regulation is designed to protect against the same risk of occurrence of fire with respect to which the standard or other regulation under this Act is in effect unless the State or political subdivision standard or other regulation is identical to the Federal standard or other regulation."2 [Emphasis added.]

It is also worth noting that the primary section of the FFA, section 4, which lays out the basis for Commission action, uses the same phraseology:

"(a) Whenever the… [Commission] finds on the basis of the investigations or research conducted pursuant to section 14 of this Act that a new or amended flammability standard or other regulation, including labeling, for a fabric, related material, or product may be needed to protect the public against unreasonable risk of the occurrence of fire leading to death or personal injury, or significant property damage… [it] shall institute proceedings for the determination of an appropriate flammability standard (including conditions and manner of testing) or other regulation or amendment thereto for such fabric, related material, or product." [Emphasis added.]

The language is clear. The fact that the phrase "standard or other regulation" is used to describe action by this agency and the State actions that are preempted is strong evidence that the same type of actions are being referenced in both instances.

The Commission has addressed the issue of whether the phrase "standard or other regulation" included judicial decisions, when it gave guidance to the public on the exemption provisions in subsection (c) of section 16, which allows States or their political subdivisions to apply to the Commission to exempt a flammability standard or other regulation of such State or subdivision from the preemptive effect of the Act. The Commission concluded that this phrase did not include court actions.3 Indeed it would be very odd for a court, or any other State entity, to petition the agency for an exemption to the federal standard because of a ruling in a particular court. As the Commission noted, "Generally, courts do not establish prospective standards or regulations applicable to a category of persons, but instead deal with the specific parties before them." The agency's interpretation of that subsection is not out of date, as some have stated. It was then, as it is now, a commonsense reading of the statutory language. That finding was tied directly to the exemption subsection. However, as has been noted above, Congress did not vary its choice of language in the three subsections of the preemption section. It seems unlikely that this phrase would mean one thing in subsection (c) but, without explanation, something else in the other two subsections.

When a preemption provision plainly does not preempt state court remedies, there is no need for a savings clause. Thus the absence of one in the FFA is not remarkable.

As the statutory preemption language is clear, looking beyond it to the legislative history of that language does not seem necessary. However, since the proposed preemption interpretive language in the Preamble attempts to rewrite the phrase "standard or other regulation" as if the wording in the statute was "requirements," and then use that potentially broader term to justify preemption of state common law, a few words must be said on the legislative history of section 16. While it is true that the 1976 House Conference Committee Report uses the word "requirements" to describe both this agency's regulatory actions and the State and local actions that are preempted, there is absolutely no indication that this shorthand for the longer and unwieldy phrase "standard or other regulation," was meant as anything more than that. In fact, the examples that are given in the report refer to state administrative standards, not court rulings. Nothing in the legislative history indicates Congress intended this language to preempt common law remedies and without a clear statement by Congress that this was intended, no preemption of court common law remedies can be assumed. There is similarly no legislative history to support that the language which the 1976 preemption section replaced ("any law of any State or political subdivision") was intended to encompass state common law.

As stated in section 4, the purpose of Commission action under the FFA is to "…protect the public against unreasonable risk of the occurrence of fire leading to death or personal injury, or significant property damage…." That is the Commission's primary responsibility. Obviously, because federal regulations are meant to have national effect, we want them to replace any non-identical state regulations which provide less protection for consumers. After the adoption of a federal regulation, no State should go through a duplicative standard-setting process (with the attendant costs that this entails for industry) when that State had the opportunity to present information to the Commission in the federal proceeding, unless of course such information was simply not available at the time of the Commission's rulemaking proceeding, or the State feels a stricter standard is essential to protect its citizens. The longer our standards are in effect, the more likely it is that new information or new technology may make stricter standards desirable. The FFA provides both a blanket exclusion from preemption for stricter State standards and regulations and an opportunity to apply to the Commission for an exemption. Thus Congress did not intend for CPSC regulations to occupy the field in fire protection related to consumer products covered by the FFA and contemplated that States might come up with better solutions.

The exclusion and exemption provisions reflect the recognition that no agency promulgates perfect regulations (although I think our agency does an extremely good job). For example, in this regulation, the T-shaped burners in the test method are meant to simulate burning bed clothes, since most beds will have sheets and blankets and other items on them when they catch fire that create a larger flame impinging on the mattress than the initial ignition source. However, the tests have shown that in many, if not most, cases (particularly with the new one-sided mattresses) the burners do not accurately reflect the effect of burning bed clothes. In a number of instances where the new mattresses failed to perform as staff hoped, the solution was to lower our expectations as to how many people the standard would save, not to make the standard tougher. Nevertheless, we do know that this standard will result in significant improvements in fire resistance over the old non-flame resistant mattresses. It appears, for the time being, that this rule is the best that can be done. But it makes no sense to risk eliminating sources of new information that might come from private litigation. Just as litigation informs our compliance activities, so should we allow it to inform our regulatory process.

I do not think any state court cases should be foreclosed by the preemption language in the FFA. The Commission has always, wisely to my way of thinking, stayed out of the business of trying to read anything more into the language of the preemption statute than is there.4 It is always possible that some state court cases will be preempted by other principles the courts may apply. But that is for the courts to decide, not the Commission. It is the courts, with specific fact patterns in front of them that are best equipped to decide whether a case should go forward or not. If we have gotten this standard right, then law suits against manufacturers should be a rarity and prevailing ones even less common. But if we have gotten it wrong, the fastest way we will find out is through people bringing lawsuits that challenge our conclusions. That people bring lawsuits in which they do not prevail is not an indication that our judicial system is broken. It is an indication that it is working.

Absent a clear mandate from Congress, the Commission should not put its thumb on the scale of justice to tip it one way or the other. We all have the same objective: keeping consumers safe from unreasonable risks of fire. Federal regulation is not the only way of achieving that goal.


The Presidential Executive Order

Finally, we have the Presidential Executive Order which has been read to require the Commission to state whether or not this regulation issued under the FFA preempts not only non-identical positive State actions issued by legislative bodies and administrative agencies, but whether it also necessarily preempts State court holdings.

When he issued the Executive Order, the President stated the purpose was "…to improve access to justice for all persons who wish to avail themselves of court and administrative adjudicatory tribunals to resolve disputes, to facilitate the just and efficient resolution of civil claims involving the United States Government, to encourage the filing of only meritorious civil claims, to improve legislative and regulatory drafting to reduce needless litigation, to promote fair and prompt adjudication before administrative tribunals, and to provide a model for similar reforms of litigation practices in the private sector and in various states.…"

The preemption language is placed in the Order under Section 3, which is entitled "Principles to Enact Legislation and Promulgate Regulations Which Do Not Unduly Burden the Federal Court System." It states that a regulation specify "in clear language the preemptive effect, if any, to be given to the regulation." Nearly every principle in this section deals with eliminating errors, using clear and specific language to reduce needless misunderstandings and to make sure all the necessary information that pertains to a regulation is included in it. Since this Order was signed in 1996, the Commission has interpreted it to mean that we should make sure each new regulation lays out the preemption language in the governing statute so that people affected by it are aware of the preemption provisions. The Commission has not felt it was required to go beyond the words of the governing statute which would risk creating misunderstandings or confusion. The President who signed this Order never expressed any dissatisfaction with the way the Commission responded to it on this subject. I do not know why there is a need now to define what the Commission considers to be preempted. But I do know that the need does not flow from this Executive Order.

I do want to thank my colleagues for responding to my request and releasing the new proposed preemption language to the public, although I still do not understand why it was withheld in the first place. One explanation I have received is that there is really nothing new in the language. If that were the case, it makes the withholding of the language even odder. Its release at the twelfth hour, buried in the tabs of the briefing package on our web site, did not give it the public exposure it deserved. The way in which it was handled may give it more exposure than intended.

It has been said that the public got notice of this new interpretation in the Notice of Proposed Rulemaking of January 13, 2005. Nothing in that language, except for the discussion of a General Counsel Advisory Opinion with regard to the preemptive effect on a California regulatory standard,5 is different from the language the Commission has been using since 1996. My staff had discussions with the Office of General Counsel about this very provision at the time it was being considered and they gave us no indication that the preemption language in that document was intended to include state court decisions. If that language was meant to alert the public that the Commission was about to embark on an interpretive exercise on preemption, it escaped not only the public's notice, but mine as well.

I would have preferred if both the Preamble language, and our General Counsel's memo, which gives the rationale behind that language, had been made public and if more time for public comment on these documents had been allowed. This would be in keeping with the one other time in which I am aware that the General Counsel's office proffered a rationale for interpreting language in one of our statutes in a restricted memo to the Commission. When a new interpretation of the term "substantial compliance" was going to be inserted in the preamble to the bunk bed rule, based on a General Counsel memo, the Commission voted unanimously to release that General Counsel memo to the public and to give interested parties ample time to respond to it. We received some very good comments on it, which helped the Commission come to a different, and unanimous, rewording of the Preamble language. That model was not followed in this case, although the outline of the General Counsel's reasoning is to be found in the language that is proposed to be inserted into the Preamble.

I am voting today to approve the text of the mattress (open-flame) rule because it is an important and needed improvement in fire safety for this country. However, I cannot support the preemption language in the Preamble which purports to expand the scope of the preemption provision in the FFA. To some, this new preemption language may not seem of much consequence in the mattress context, but it (or something very like it) will be inserted in every new regulation the Commission issues. The consumer's right to sue a manufacturer, potentially any manufacturer of a regulated consumer product, for injuries from that product, may be seriously curtailed. That surely is not without consequence.

The courts will eventually decide how much deference to give the agency's interpretation of the preemption provision. Perhaps they will heed the opinion of Supreme Court Justice Sandra Day O'Connor when she said, "It is not certain that an agency regulation determining the pre-emptive effect of any federal statute is entitled to deference…." 6

If we were the ones having to sit in judgment of whether a potential lawsuit should be preempted, then we would have to make such a determination. But we are not, and we should not.

1 There is a discussion about preemption of a California Bureau of Home Furnishings standard in the Preamble to the Notice of Proposed Rulemaking to this regulation, which is discussed later in this statement.
2 Subsection (b) was described in the preceding paragraph; subsection (c) is the provision by which States can apply for exemption for the preemption provisions for higher State standards.
3 See Fed. Reg. 3414 (January 30, 1991).
4 It is worth noting that Conference Committee Report 94-1022, which described the change in the preemption language in the FFA, contains language that has been construed by the agency's Office of General Counsel to mean that our current cigarette ignition mattress standard would preempt State standards dealing with open-flame ignition of mattresses. To date, the Commission has treated cigarette ignition and open flame ignition of complex products as very different fire scenarios requiring different types of standards. I believe the Report language was focusing on different testing methods for determining compliance with the same fire scenario. It used the flammability of a simple piece of fabric as the example of when a standard that used a match to test a fabric's flammability did not differ from a standard that used a lit cigarette. And for a single piece of fabric stretched in a holder, these test methods probably would result in no significant difference in fire protection. But the Commission has found, when dealing with complex structures such as upholstered furniture and mattresses, which contain multiple materials all of which may react differently to a smoldering or to a flaming ignition, that there are differences in the way the fires are started and in the way in which the fires progress and that different product construction methods are needed to address each type of fire situation. That we started an open-flame mattress proceeding when we already had a cigarette ignition mattress standard is proof of that. Technology may eventually overcome the need to have separate standards in these situations but they certainly had not done so at the time the Conference Committee Report was written.
5 See footnote 2. This Conference Report language is now being used to bolster the argument that FFA regulations preempt state common law remedies. This is not supported by anything in the legislative history.
6 Medtronic, Inc. v. Lohr, 518 U.S. 470 at 512, 116 S.Ct. 2240 (1996).

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