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Your Space - California Car Wash Fundraisers and Environmental Law
Many non-profit groups are feeling upset that they are allowed to do car wash fundraisers in some California Cities. It is not that the government officials are against your groups raising money, it is that they worry where are the soapy dirty water is going. It is a problem and it might be good for you to understand some of the history behind the rule
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
s rather than get upset over it.
HISTORY
Well it all started many years ago when Congress passed the Federal Clean Water Act in 1972 during the Nixon Administration. This was in response to major pollution issues involving polluting the nation’s waterways from factories, strip mining and sewage treatment plants or lack thereof. It was actually quite
HISTORY
Well it all started many years ago when Congress passed the Federal Clean Water Act in 1972 during the Nixon Administration. This was in response to major pollution issues involving polluting the nation’s waterways from factories, strip mining and sewage treatment plants or lack thereof. It was actually quite
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
a problem. It was an ecosystem disaster causing disease and death to wildlife and some people. When it was discovered just how bad the problem really was, the federal government empowered the states to take care of the issues within their state. The states enacted state laws to help fix the problem. Meanwhile, the federal government tightened standards
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
forcing states to tighten their standards or be in violation. With the threat of withholding federal monies to the states, the states continued to make more and more laws. Industry obviously wasn’t happy and even government agencies were unable to comply with the laws they made. So, target dates were enacted to give time for everyone to comply. Overni
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ght environmental consulting firms sprung up along with a whole new industry of environmental equipment and product manufactures, many of whom weren’t even in compliance themselves. Of course, all good things take time and cleaning up our water is obviously a good thing.
The State of California divided the state into nine different regions realizing t
The State of California divided the state into nine different regions realizing t
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
hat each region had different pollution problems based on industry types, demography and population in the areas. These regions were called ‘Regional Water Quality Control Districts’ (RWQCD). These were all controlled by the State Board that was defined by the Federal Clean Water Act as the State Water Resources Control Board (SWRCB). Once the problem
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
was broken down into smaller pieces things started to change for the better.
The SWRCB was formed in California and is commonly called ‘The State Board’. The State Board regulates Water Quality Control, which is any activity or factor that might affect the quality of waters of the state and includes the prevention and correction of water pollution and
The SWRCB was formed in California and is commonly called ‘The State Board’. The State Board regulates Water Quality Control, which is any activity or factor that might affect the quality of waters of the state and includes the prevention and correction of water pollution and
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
nuisance. This sounds very encompassing and the State Board has a lot of power. Luckily, with the combined efforts of industry, government and the people, they now understand the issues enough to make intelligent decisions and they fully understand that your organization needs to earn money. Thus, rather than prevent and outlaw activities, everyone is
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
working on solutions and procedures to allow responsible discharges creating a win-win situation for everyone.
Recently, the State Water Quality Control Boards asked the counties to submit for approval and receive permits to discharge the same waters they’ve been discharging for years. These permits were called NPDES permits. This stands for National
Recently, the State Water Quality Control Boards asked the counties to submit for approval and receive permits to discharge the same waters they’ve been discharging for years. These permits were called NPDES permits. This stands for National
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
Pollution Discharge Elimination System. Most counties assigned an existing department to work on this permit. More likely than not, it is the county’s Flood Control Department. Unfortunately, this part of the county deals with permits for land development, bridges, infrastructures, etc. Until now, they knew very little about pollution. Some counties t
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
urned this responsibility over to the Environmental Health Services Department who in turn worked with the Flood Control Department which controls storm drains. The NPDES permits are approved by the state for local county urban runoff discharges. Each city in each county through municipal codes is supposed to pass ordinances and come up with a plan for
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
controlling their local runoff/pollution. The county remains responsible to the state and the states to the Federal Government. The NPDES requirements are an offspring of the EPA, Environmental Protection Agency even though they are enforced, permitted and regulated locally by cities, counties and states.
The actual law that is used to enforce these
The actual law that is used to enforce these
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
statutes can be found in 13.260 – 13.265 of the California Water Code. At one point it actually reads:
"No person, or persons may discharge water to any waterways without permission or a permit from a state regional water quality control board."
This sounds pretty absolute doesn’t it. It is against the law for you to take a glass of water from your s
"No person, or persons may discharge water to any waterways without permission or a permit from a state regional water quality control board."
This sounds pretty absolute doesn’t it. It is against the law for you to take a glass of water from your s
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ink, walk over to a storm drain and pour the water in the drain. This in itself would obviously not hurt the environment, but by granting absolute power the Regional Water Quality Control Boards can look at everything on a case-by-case basis. So do be serious about your water after you wash those cars.
STORM WATER DISCHARGE
City, county and state gov
STORM WATER DISCHARGE
City, county and state gov
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
ernments know that car washing has always been a favorite fundraiser for sports teams, scout troops, schools and other non-profit groups. Due to the low capital investment costs, car wash fundraisers can generate significant amounts of profit. For the last ten years government agencies especially in California have been working with industry to come up
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
with solutions to clean up our water. Today the waterways of America are significantly cleaner than they were in the past even though many regions are more heavily populated. It’s been working great. Now we are going one step further. No pollution from any source, even mobile dog groomers. Only in the last few years have government agencies decided th
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
at the adverse environmental impact is too great to allow car wash fundraisers. Along with strong lobbying from fixed site car wash owners, some cities and counties have actually outlawed these fundraisers unless certain procedures are followed to insure that no waste wash water enters storm drains, ditches or waterways.
Their reasoning is this: Dirty
Their reasoning is this: Dirty
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
water containing soaps and detergents, residues from exhaust fumes, gasoline and motor oils is washed off of the cars and flows into nearby storm drains. Unlike the water we use in our homes and businesses that goes down the drain and is treated at sewer treatment plants, water that goes into storm drains flows directly into rivers, bays, oceans and l
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
akes without any kind of treatment. Obviously one car wash fundraiser by itself will create little if any adverse environmental impact. But government agencies know that collectively car wash fundraisers contribute significant pollution.
They also realize that biodegradable soaps do not lessen the impact. This is because biodegradable only means that
They also realize that biodegradable soaps do not lessen the impact. This is because biodegradable only means that
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
the soap will degrade over time. So does plutonium, it just takes longer. Soaps and car wash products are still toxic to aquatic life even if they are biodegradable. Think on this a bit. If you really want to have the city allow you to do a car wash fundraiser you are going to have to figure out how to keep the dirty soapy water out of the storm drain.
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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