Subject: Re: Sludge Watch ==> US: Report says stingy funding
put Food & DrugAdmin in crisis
Date: 1/8/2008 8:11:42 A.M. Pacific Standard Time
From: Stevens.Rick@epamail.epa.gov
Reply To:
To: maureen.reilly@sympatico.ca
CC: BynJam@aol.com, edo_mcgowan@hotmail.com,
ezh1@cornell.edu, rubinhial@cox.net,
Bastian.Robert@epamail.epa.gov
BCC:
Sent on:
Hi Maureen,
I am getting back to you on your December 9, 2007 e-mail. I will
provide you with a regulatory interpretation to your question
concerning 40 CFR Part 503 harvesting, grazing, and public
access restrictions. However, any EPA-related response
concerning enforcement and compliance will have to come from
EPA Regional Offices and the Office of Enforcement and
Compliance Assurance.
For the most part, the Part 503 regulation was written to be
'self-Implementing', which means that persons are required to
follow the rule and citizen suits or EPA can enforce the regulation
even if they have not been issued a permit for such activities. EPA
can take enforcement actions against persons who violate the
Part 503 requirements (permitted or not). As a result, treatment
works must start monitoring and keeping records of biosolids
quality, and in many cases land appliers must start keeping
records of loading rates and locations receiving biosolids, and
must comply with pollutant limits and other technical standards,
even in the absence of a Federal permit.
Under Part 503, land application includes all forms of applying
biosolids to the land for beneficial uses at agronomic rates (rates
designed to provide the amount of nitrogen needed by the crop or
vegetation grown on the land while minimizing the amount that
passes below the root zone). These uses include application to
agricultural land, such as fields used for the production of food,
feed, and fiber crops, pasture and range land; non-ag land, such
as forests; disturbed lands, such as mine spoils, construction
sites, and gravel pits; and public sites, such as golf courses,
parks, and home lawns and gardens.
The rule applies to the person who prepares biosolids for land
application or applies biosolids to the land. These parties must
obtain and provide the necessary information needed to comply
with the rule. These parties must obtain and provide the
necessary information needed to comply with the rule.
The regulation establishes two levels of biosolids quality with
respect to heavy metal concentrations (pollutant ceiling
concentrations and pollutant concentrations for 'high quality'
biosolids, two levels of quality with respect to pathogen densities
(Class A and Class B), and two types of approaches for meeting
vector attraction reduction (biosolids processing or the use of
physical barriers). The EPA and Part 503, Standards for the Use
and Disposal of Sewage Sludge, imposes no restrictions for
controlling pathogens in Class A biosolids. Biosolids
meeting Federal and State Class A requirements for treatment
and vector attraction reduction may be used on appropriate sites
without further restrictions.
When biosolids meeting the Class B quality standard are
land-applied, restrictions are imposed on the farmer or land
owner according to the following calendar:
For the first 30 days after application: No food, feed, or fiber
crops can be harvested. No grazing of animals is permitted.
Public access to the area must be restricted.
For the first year following application: Access to application
sites with a high potential for public exposure, such as an
urban park or urban construction site, must be restricted.
Similarly, turf cannot be harvested for use on lawns or other
areas with a high potential for public exposure.
For the first 14 months following application: No food crops with
harvested parts that touch the sludge or soil can be harvested.
For the first 20 months following application: No food crops with
harvested parts below the soil surface can be harvested.
For the first 38 months following application: Food crops with
harvested parts below the surface of the land cannot be
harvested unless the sewage sludge remains on the soil
surface for at least four months before it is incorporated into the
soil.
I trust this addresses your question. Please contact me if you have
further questions.
Thanks,
Rick Stevens
202-566-1135
202-566-1139 fax
stevens.rick@epa.gov
"Maureen Reilly"
<maureen.reilly@
sympatico.ca> To
Rick Stevens/DC/USEPA/US@EPA
12/09/2007 05:34 cc
PM rubinhial@cox.net,
ezh1@cornell.edu,
edo_mcgowan@hotmail.com,
BynJam@aol.com
Subject
Re: Sludge Watch ==> US: Report
says stingy funding put Food &
DrugAdmin in crisis
Dear Rick
I would like to know how farmers control what happens to the
grain they sell...how do they insure it doesn't go into making food
for people?
How do soy bean growers know it wont be used for tofu?
How is it enforced?]
Indeed...since the FARMERS don't know where the sold grain etc
goes...how does the sewage treatment plant who is responsible
for enforcement know where the crop has gone. How can they
ensure the sludged crop wasn't used for food?
Maureen Reilly
>From: "The Rubins" <rubinhial@cox.net>
>To: "Maureen Reilly"
><maureen.reilly@sympatico.ca>,<Sludgewatch-l@list.web.net>
>CC: <Stevens.Rick@epamail.epa.gov>
>Subject: Re: Sludge Watch ==> US: Report says stingy funding
put Food & DrugAdmin in crisis
>Date: Sun, 9 Dec 2007 17:29:19 -0500
>
>Rick:
>
>you may want to respond to Maureen Reilly's assertion that the
part 503 standards cannot be nforced re. harvesting
restrictions/waiting periods.
Apparently she does not believe that the language in the part 503
Standards has any meaning.
>
>thanks and Cheers
>
>alan
>
>----- Original Message ----- From: "Maureen Reilly"
><maureen.reilly@sympatico.ca>
>To: <Sludgewatch-l@list.web.net>
>Sent: Thursday, December 06, 2007 9:59 AM
>Subject: Sludge Watch ==> US: Report says stingy funding put
Food & DrugAdmin in crisis
>
>
>>Sludgewatch Admin:
>>
>>With food safety crippled, it isn't wise to use sewer wastes
(biosolids) to fertilize crops, and it isn't wise to use sewage
effluent for the irrigation of leafy greens
>>
>>The US regs have no mechanism for enforcement of sludge
waiting periods ... the period that farmers are supposed to wait
between spreading sludge and harvesting potatoes, carrots, hay,
turf, etc. The farmer doesn't generally have the permit to spread
sludge...so since the farmer isn't the permit holder the farmer isn't
bound to respect the 503 requirements.....the sludge hauler
would have to have some kind of contract to make the thing
>>enforceable in civil court.
>>
>>Well how long would that take...? And who even knows if those
contracts exist? And where is the food in the meanwhile?
>>
>>In the grocery store.
>>
>>
>>Here in Ontario the Ministry of Environment refuse to say how
they are enforcing pathogen limits in sewage sludge... stats show
that some biosolids are heading out at 12 million fecal coliform
per gram.
>>............................................
>>US: Report says stingy funding has put FDA in crisis
>>05.dec.07
>>CIDRAP News
>>
>>
>>http://www.cidrap.umn.edu/cidrap/content/fs/food-disease/news
/dec0407fda.html
>>
>>Safety inspectors still write their reports by hand, food
processing plants are inspected once every 10 years at best, only
two people work full-time on pet-food safety, and critical
information is locked up in piles of warehoused paper
documents.
>>Those are a few symptoms of the poor condition in which the
US Food and Drug Administration (FDA) finds itself after decades
of inadequate funding and growing responsibilities, according to
a new report by a special FDA committee that was assigned to
assess the agency's scientific and technological capabilities.
The bottom line is that "American lives are at risk," says the
60-page report, titled "FDA Science and Mission at Risk: Report of
the Subcommittee on Science and Technology."
>>The report says the agency is losing its ability to keep up with
>>scientific advances, its regular staff has stayed about the same
size for 20 years, and its information technology (IT) systems are
obsolete and unreliable.
>>
>>"We found that FDA's resource shortfalls have resulted in a
plethora of inadequacies that threaten our society-including, but
not limited to, inadequate inspections of manufacturers, a dearth
of scientists who understand emerging new technologies,
inability to speed the development of new therapies, an import
system that is badly broken, a food supply that grows riskier each
year, and an information infrastructure that was identified as a
source of risk in every Center and program reviewed by the
Subcommittee," the report states.
>>
>>The report suggests the agency may need as much as twice
its current level of funding to equip it properly to fulfill its mission.
>>The document's release comes less than a month after the
Bush administration released an import safety and food
protection plan triggered by a series of tainted imports, including
contaminated pet food and toys with lead paint, plus recent
domestic food contamination episodes, such as instances of
Salmonella in peanut butter and E coli in fresh produce.
>>The FDA' s mission includes regulating about 80% of food sold
in the United States, plus all drugs, human vaccines, and medical
devices, the report notes. The products the agency regulates
account for about 25 cents of every consumer dollar spent-about
$1 trillion per year.
>>A year ago, FDA Commissioner Andrew von Eschenbach
asked his advisory board, called the FDA Science Board, to name
a subcommittee to weigh whether the agency has the scientific
and technologic capacity to support its regulatory
>>mandate, the report says. The subcommittee that was
subsequently appointed included three members of the Science
Board and other experts representing industry, academia, and
other government agencies.
>>
>>Soaring demands, static funds >>
>>
>>The subcommittee found two reasons for the "precarious"
condition of science at the FDA:
>>* The demands on the agency have soared because of "the
extraordinary advance of scientific discoveries, the complexity of
the new products and claims submitted to FDA for pre-market
review and approval, the emergence of challenging safety
problems, and the globalization of the industries that FDA
regulates."
>>
>>* Funding has not kept pace with the scientific demands on the
agency. The funding shortage has forced the FDA to operate in a
crisis-management or "firefighting" mode and kept it from
building "a culture of proactive regulatory science," the report
says. This is especially true of the agency's two food safety
centers, the Center for Food Safety and Applied Nutrition (CFSAN)
and the Center for Veterinary Medicine (CVM). Crisis
management at the two centers "has drawn attention and
resources away from FDA's ability to develop the science base
and infrastructure needed to efficiently support innovation in the
food industry, provide effective routine surveillance, and conduct
emergency outbreak investigation activities to protect the food
supply," the document reads.
>>It says the FDA needs a group of scientists who have the ability,
freedom, and support to apply the latest tools of biology,
chemistry, and bioinformatics to food safety regulation. "These
individuals must be isolated from acute regulatory crises."
>>
>>Food inspections 'appallingly' rare
>>
>>The subcommittee found the FDA has "an appallingly low
inspection rate" for both domestic and imported foods. "During
the past 35 years, the decrease in FDA funding for inspection of
our food supply has forced FDA to impose a 78 percent reduction
in food inspections, at a time when the food industry has been
rapidly expanding and food importation has rapidly increased.
FDA estimates that, at most, it inspects food manufacturers once
every 10 years," and it inspects no retail food stores or farms.
As an example of problems caused by scanty funding, the report
cites the US experience with bovine spongiform encephalopathy
(BSE), or mad cow disease.
>>When BSE emerged in Europe, consumers and the cattle
industry looked to the FDA to ensure that the disease would not
spread to the United States via cattle feed, which the FDA
regulates. "But Agency officials were denied the funds to bring the
feed industry into rapid compliance with the new feed
regulations, and the disease did appear in the US," the report
says.
(The first US case, found in December 2003, was in a
Canadian-born cow; several more cases have been discovered
since then.)
>>The recent problems with imported pet food contaminated with
the chemical melamine also point up the FDA's struggles, the
panel reported. Pet food sales total $15 billion to $20 billion a
year, and the CVM received more than 18,000 phone calls about
the melamine contamination-but the CVM "is able to devote only
two people working full-time on pet food issues."
>>The authors recommend that the food safety centers
collaborate more with other research programs, such as those of
the Centers for Disease Control and Prevention, National
Institutes of Health, and Department of Homeland Security.
However, the centers still need their own scientific expertise,
the report says. Overall, the FDA doesn't have enough well-trained
scientists, the report asserts. The number of "appropriated
personnel" is about the same now as it was two decades ago,
resulting in "major gaps of scientific expertise in key areas." The
turnover rate for FDA scientists in key areas is twice that of
other government agencies, and the agency spends too little on
professional development to enable the staff to keep pace with
scientific advances.
>>
>>The agency should add several new positions to boost its
scientific firepower and provide for a "coherent scientific structure
and vision," the report says. First, the recently created position of
deputy commissioner/chief medical officer should be broadened
and renamed "deputy commissioner of scientific and medical
affairs." This person should have authority to develop and
oversee all science activities and ensure the adequacy of
scientific expertise. Other recommended new jobs include
chief scientific officer, a deputy director for science within each
FDA center, and a director of extramural collaborations and
training.
>>
>>IT systems disturbingly poor
>>
>>The report saves some of its strongest language for critiquing
the FDA's IT infrastructure. The panel was "extremely disturbed"
by the condition of the IT systems. The report continues, "The IT
situation at FDA is problematic at best-and at worst it is
dangerous. . . . Systems fail frequently, and even small systems
are unstable-most recently during an E. coli food contamination
investigation.
>>"More importantly, reports of product dangers are not rapidly
compared and analyzed, inspectors' reports are still handwritten
and slow to work their way through the compliance system, and
the system for managing imported products cannot communicate
with Customs and other government systems."
>>
>>Because of inadequate backup systems, recent systems
failures have erased FDA data, the report continues. Further,
"Critical data reside in large warehouses sequestered in piles
and piles of paper documents" for which there is no backup.
>>
>>The report lists various estimates by others of the resources
needed to restore the FDA's scientific capabilities. For example,
the Coalition for a Stronger FDA has said that an increase of 15%
a year for the next 5 years is needed. But the authors submit that
this still would be inadequate.
They suggest doubling the current funding-from about 1.5 cents
to 3 cents per American per day. (Assuming a US population of
300 million, that would mean raising the budget from about $1.64
billion to $3.28 billion.)
>>
>>
>>
>>
>
>
>--------------------------------------------------------------------------------
>
>
>>---------------------------
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>>
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>>
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>>
Subject: Re: Sludge Watch ==> US: Report says stingy funding
put Food & DrugAdmin in c...
Date: 1/14/2008 1:10:54 P.M. Pacific Standard Time
From: BynJam
Reply To:
To: Stevens.Rick@epamail.epa.gov, maureen.reilly@sympatico.ca
CC: edo_mcgowan@hotmail.com, ezh1@cornell.edu,
rubinhial@cox.net, Bastian.Robert@epamail.epa.gov
Hi Rick,
Your regulatory interpretation to Maureen's question concerning
40 CFR 503 harvesting, grazing, and public assess restrictions
was rather misleading. As examples, EPA Regional Offices
either promote sludge use as a fertilizer or as in the case of John
Dunn, Kansas City EPA Regional Office , refuse to get involved,
just as the Office of Enforcement and Compliance has refused to
get involved as noted in the 2002 EPA OIG Report.
As you state, the Part 503 was written to be "self-implementing"
which meant "persons" ( the approximately 20,000 municipal
sewage treatment plants) were required to follow the rules and
submit permit applications to EPA within 120 day after February
19, 1993 (FR. 58, page 9404). The Part 503 regulation is the only
rule which does not provide for citizens suits since it is a policy
regulation. The City of Kansas City, Missouri is an example of
where the treatment plant failed to record loading rates for some
chemicals. For other chemicals, when the loading rate was
reached, the City simple started counting from zero. Neither EPA
or the state was concerned with excess levels of arsenic.
Under Part 503, "When the sewage sludge is not used to
condition the soil or to fertilize crops or vegetation grown on the
land, the sewage sludge is not being land applied. It is being
disposed of on the land. In that case, the requirements
in the subpart on surface disposal in the final Part 503
regulation must be met." The problem is, That at the ceiling level
of arsenic in Part 503.13, the biosolids can not be disposed of
under the subpart on surface disposal in the final Part 503.23.
Plus, you allow unlimited Chromium in biosolids, which would be
illegal under the subpart on surface disposal in part 503.
According to Part 503 the rule only applies to a "person" who
generates or prepares sludge ( treatment plant or derives
material from sludge. Since only seven states currently have EPA
approval to issue sludge use permits, how many of the 20,000
treatment plants are being monitored by EPA?
Where in the Part 503 regulation can you find that EPA
established two levels of sludge or biosolids quality in respect to
heavy metal concentrations? Where do you find "high quality" or
"exceptional quality" sludge or biosolids mentioned in Part 503?
Why did EPA establish two levels of pathogen densities based on
a strain of E. coli that grows at 112.1 (44.5C) degrees, doulbes
every 20 minutes and which have been found to be pathogenic?
Why has EPA ignored the vector attraction requirement for Class
A: 1) no significant amount of sludge/biosolds on the surface after
1 hour; 2) shall be injected below the surface within 8 hours of
treatment; or 3) incorporated in the soil within 8 hours after
treatment? On a surface disposal site, sludge must be
incorporated in the soil within 6 hours.
Where in the Part 503 are any restrictions for Class B imposed on
the farmer or private land owner who does not have to inform the
buyer? As an example: "(l) Food crops are crops consumed by
humans. These include, but are not limited to, fruits, vegetables,
and tobacco." Even corn is a food crop consumed by humans.
Why was food crops added to the 30 day restriction in the final
Part 503? The 2007 Oregon Biosolids document, Fertilizing with
Biosolids does not mention food crop restrictions, but it does
mention exception vegetable crops grown on sludge/biosolids.
What private farmer owner would accept sludge/biosolids if they
knew they had to wait 14 months before harvesting vegetables for
human consumptions, much less for 20 months or 38 months? It
would appear the regulation is for wastewater treatment plants
who owned the farm. In Kansas City, it was found that pathogen
contaminated runoff from the City's sludge disposal farm site
polluted the neighboring farm a year after sludge disposal, where
Salmonella and E. coli levels were each 800,000 cfu per 100
grams of soil. As EPA's Dr. Lewis noted in the 1999 article
Sludge Magic at EPA, E. coli was also found at a level of 650,000
cfu per 100 grams of soil on land the City claimed had not
received sludge since 1992.
Don't you think it was rather rude to mislead our Canadian
cousin? Especially, since EPA admitted in 1995, there was no
cancer risk assessment for heavy metals or chemicals or
pathogens.
Best to you,
Jim Bynum
EPA ATTEMPTS TO ANSWER QUESTION ON PART 503 FOOD CROP RESTRICTIONS
Rick Stevens (biosolids coordinator) apparently has not read the complete regulation.