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FSIS Ass. of the Equivalence of the Canadian Insp report OIG

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flounder

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----- Original Message -----
From: "Terry S. Singeltary Sr." <[email protected]>
To: <[email protected]>
Sent: Thursday, January 12, 2006 9:47 AM
Subject: Food Safety and Inspection Service Assessment of the Equivalence of the Canadian Inspection System Report No: 24601-05-HY OIG


##################### Bovine Spongiform Encephalopathy #####################


Subject: Food Safety and Inspection Service Assessment of the Equivalence of the Canadian Inspection System Report No: 24601-05-HY OIG
Date: January 12, 2006 at 7:22 am PST

Audit Report

Food Safety and Inspection Service

Assessment of the Equivalence of the

Canadian Inspection System

Report No. 24601-05-Hy December 2005


snip...


Executive Summary

Food Safety and Inspection Service Assessment of the Equivalence of the Canadian Inspection System (Audit Report No. 24601-05-Hy)

Results in Brief We evaluated the Food Safety and Inspection Service’s (FSIS) assessment of the equivalence of the Canadian inspection system for meat and poultry products. In a November 6, 2003, memorandum, the FSIS Administrator and the Under Secretary for Food Safety identified serious concerns with the Canadian inspection system. They noted in the memorandum that these concerns had the potential for compromising public health. We found FSIS did not timely address these serious concerns. For example, in July 2003, FSIS identified that Canadian inspection officials were not enforcing certain pathogen reduction and Hazard Analysis and Critical Control Point (HACCP) system regulations. These same types of concerns were identified again in June 2005, almost 2 years later.

Timely actions were not taken because FSIS does not have protocols or guidelines for evaluating deficiencies in a country’s inspection system that could jeopardize a country’s overall equivalence determination. In addition, FSIS did not institute compensating controls (e.g., increased port-of-entry testing) to ensure that public health was not compromised while deficiencies were present. Over 4.4 billion pounds of Canadian processed product entered U.S. commerce from January 1, 2003 through May 31, 2005. In FSIS’ information system, the products were categorized as cuts and trimmings of raw product as well as products with additional processing from pork, veal, beef, poultry, and lamb. These products were produced and allowed to be exported to the United States even though FSIS officials questioned the equivalence of the Canadian inspection system.

FSIS regulations1 require foreign inspection systems to provide standards equivalent to those of the United States. These requirements include the implementation of sanitation controls and HACCP requirements. Sanitation controls cover all aspects of facility and equipment sanitation, the prevention of actual or potential instances of product cross-contamination, good personal hygiene practices, and good product handling and storage practices. All plants must develop, adopt, and implement a HACCP plan for each of their processes. Under HACCP, plants identify critical control points during their processes where hazards such as microbial contamination can occur, establish controls to prevent or reduce those hazards, and maintain records documenting that controls are working as intended.

In July 2003, as part of an onsite review, FSIS identified serious concerns with the Canadian inspection system. These concerns included the

1 Title 9, Code of Federal Regulations (C.F.R.) § 327.2 (a) (2) and 9 C.F.R. § 381.196 (a) (2), January 1, 2005 edition.

USDA/OIG-Audit No. 24601-05-Hy Page ii

insufficient implementation of sanitation controls and HACCP requirements by establishments and the lack of enforcement in these areas by Canadian inspection officials. Based on these concerns, FSIS proposed an enforcement review in 2004. (Enforcement reviews can lead to a determination that a country’s system is not equivalent to U.S. standards and, thus, not eligible to export to the United States). The proposed 2004 enforcement review was not conducted and FSIS officials did not reassess Canada’s implementation and enforcement of sanitation controls and HAACP requirements until almost 2 years later. When FSIS officials finally returned to Canada in May 2005, they continued to find the same types of deficiencies they had found in 2003. FSIS should analyze the deficiencies identified in the 2003 and 2005 reviews to determine whether immediate actions are needed to address concerns regarding public health and if additional enforcement measures are needed.

FSIS’ analysis of the regulations governing the Canadian inspection system identified two areas which may not be equivalent to the United States inspection system. FSIS found that Canadian policy allowed less than daily inspection coverage in processing establishments. By contrast, FSIS has a long established history of requiring the presence of an inspector in a U.S. processing establishment at least once per shift per day. FSIS also identified differences in the testing performed for Listeria monocytogenes. Canadian inspection officials require establishments to perform risk-based environmental sampling, as opposed to the finished product sampling required by FSIS.

In a management alert to the FSIS Administrator in July 2005, we reported that FSIS had not taken timely action to resolve the agency’s June 2003 finding that Canada does not require daily inspection coverage at processing establishments that export product to the United States. In addition, FSIS’ actions regarding Canadian processing establishments were not consistent with how the agency treated similarly situated countries. When FSIS identified less than daily inspection in establishments in Australia in June 2004, and in Belgium in July 2003, the establishments were immediately delisted and no longer allowed to export product to the United States. According to FSIS officials, Australia and Belgium did not pursue an equivalence determination, which was pursued by Canada. In response to our recommendations, FSIS agreed to initiate a number of actions to ensure that an equivalence determination was made regarding daily inspection coverage. However, FSIS asserted that a final decision could not be made until 2007. In the interim, FSIS agreed to implement measures that the agency believes will ensure there is no increased risk to the public health in the United States. These measures included doubling the sampling of Canadian shipments and increasing the presence of Canadian inspection officials in processing establishments exporting to the United States.

USDA/OIG-Audit No. 24601-05-Hy Page iii

Recommendation

In Brief FSIS needs to develop and implement protocols for postponing or canceling a scheduled enforcement review and for determining which equivalence deficiencies would call into question a country’s overall equivalence to U.S. standards. In addition, FSIS should analyze the deficiencies identified in the 2003 and 2005 reviews of the Canadian inspection system to determine whether additional actions are needed to address concerns regarding public health. Finally, FSIS needs to develop an action plan for determining whether the Canadian inspection system control for Listeria monocytogenes in ready-to-eat products is equivalent to that of the United States.

Agency Response

FSIS agreed with the report’s recommendations. We have incorporated the agency’s response in the Findings and Recommendations section of this report, along with the OIG position. The response is included as Exhibit A.

OIG Position

Based on the response, we were able to reach management decision on the report’s five recommendations.



snip...


however, these reviews did not focus on the differences identified in 2003. These two reviews primarily evaluated the implementation of FSIS’ requirements related to BSE. In December 2004, FSIS officials performed a review of 15 Canadian establishments that slaughtered cattle and calves for export to the United States. This review found that Canadian establishments implemented FSIS’ requirements for BSE and controlled the use of hormone implants in calves. In February 2005, FSIS officials visited two Canadian beef slaughter establishments and three establishments that processed this product. This review found that

USDA/OIG-Audit No. 24601-05-Hy Page 8

7 Specified risk materials are prohibited from use for human food. The materials include the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the traverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), dorsal root ganglia of cattle 30 months of age and older, tonsils, and distal ileum of the small intestine of all cattle.

Canadian inspection officials adequately implemented FSIS’ rules regarding BSE and specified risk materials.7

• Serious Concerns Continue in 2005. In May 2005, FSIS initiated a more thorough examination of the Canadian inspection system. FSIS visited 35 establishments, which included 3 meat slaughter establishments, 21 meat and poultry processing establishments, and 11 meat and poultry establishments that had both slaughter and processing operations. FSIS also evaluated operations for residue and microbiological testing at 12 laboratories. The review was completed in June 2005, and FSIS officials continued to find a number of deficiencies that call into question the equivalence of the Canadian inspection system. As in 2003, the deficiencies included the insufficient implementation of sanitation controls and HACCP requirements by establishments and the lack of enforcement in these areas by Canadian inspection officials. FSIS officials noted, but did not report, less than daily inspection at 17 processing establishments.

- In 21 of the 35 establishments, FSIS officials found that the Canadian inspection system did not have adequate sanitation controls. FSIS continued to find that Canadian establishments did not ensure sanitation controls were adequately implemented or evaluated for effectiveness. In addition, the establishments did not take corrective actions when sanitation controls failed to prevent direct product contamination or adulteration and did not maintain daily records of these activities.



- FSIS officials found that Canadian inspection officials did not implement certain HACCP requirements in 19 of the 35 establishments. FSIS again found that Canadian establishments were deficient in validating their HACCP plans, documenting corrective actions, and reassessing the adequacy of the plans.

- As part of the review of specific establishments, FSIS again evaluated whether Canadian inspection officials adequately enforced FSIS requirements. FSIS officials found that the Canadian inspection system did not have adequate controls to ensure FSIS requirements were enforced. FSIS officials identified deficiencies in the areas of sanitation controls and HACCP requirements that had not been previously noted by Canadian inspection officials. This condition occurred in 29 of the 35 establishments visited by FSIS officials.

USDA/OIG-Audit No. 24601-05-Hy Page 9

In 2003, FSIS identified concerns which caused the agency to question the equivalence of the Canadian inspection system and to express concern about U.S. public health. The same types of concerns were identified in the review completed in June 2005. FSIS should analyze the deficiencies identified in the 2003 and 2005 reviews to determine whether immediate actions are needed to address concerns regarding public health and if additional enforcement measures are needed.

• Less Than Daily Inspection in Processing Establishments. ...


snip...



http://www.usda.gov/oig/webdocs/24601-05-HY.pdf



Greetings,


question please, i do no understand the part that ;


This review found that

USDA/OIG-Audit No. 24601-05-Hy Page 8

>>>Canadian inspection officials adequately implemented FSIS’ rules regarding BSE and specified risk materials.7<<<


how in the world can all these concerns about HACCP come about, with no ramifications to BSE/SRMs/crosscontam. etc. ???


TSS



From: Terry S. Singeltary Sr. [[email protected]]
Sent: Tuesday, July 29, 2003 1:03 PM
To: [email protected]
Cc: [email protected]; [email protected]; BSE-L
Subject: Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION
TO DOCKET 2003N-0312]

Greetings FDA,

my name is Terry S. Singeltary Sr., i lost my mother to hvCJD
(Heidenhain Variant Creutzfeldt Jakob Disease).

i would kindly like to comment on the proposed HACCP method of
detecting and or preventing TSEs in the human/animal feed supply.

it seems to me by implementing something that was designed for Astronauts
instead of cattle, something that the GAO has already stated is terribly
flawed (HACCP), i find it very disturbing to continue to insist on refusing
to use rapid TSE TESTING in sufficient numbers to find TSEs, as with
other Countries that they too once thought they were BSE free. for example,
it took Italy 1 MILLION rapid TSE tests since 2001 to find 102 cases of
BSE. THE USA has only tested 48,000 cattle in the 14 years of surveillance.
there is documented proof that indeed the USA cattle have been infected
with a TSE for decades, but the FDA/USDA and other USA Gov. agencies
continue to conveniently ignore these findings. YOU must not ignore
what Richard Marsh found. Plus, you must not ignore Asante/Collinge new
findings that BSE transmission to the 129-methionine genotype can lead
to an
alternate phenotype that is indistinguishable from type 2 PrPSc, the
commonest
_sporadic_ CJD. The USA has been feeding ruminant by-products back to
cattle, deer, elk and sheep for decades, and TSEs in these species have been
recycled for feed for decades in the USA. The rendering process here in the
USA will not kill this agent. to implement any HACCP over massive rapid
TSE testing is only prolonging the inevitable, and will only allow the
agent to
spread further. it is simply a band-aid approach to something that needs a
tourniquet...

3. Meat and Poultry: Better USDA Oversight and Enforcement of Safety

Rules Needed to Reduce Risk of Foodborne Illnesses. GAO-02-902, August
30.

FSIS Is Not Ensuring that Plants' HACCP Plans Meet Regulatory
Requirements

snip...

According to FSIS's food safety systems correlation reviews, inspectors
are not consistently identifying and documenting failures of plants'
HACCP plans to meet regulatory requirements. Furthermore, FSIS does
not expect its inspectors to determine whether HACCP plans are based on
sound science--the cornerstone of an effective plan. While in-depth
verification reviews examine the scientific aspects of HACCP plans, they
have been conducted in very few plants, and consumer safety officers
hired to review the scientific soundness of HACCP plans may take several
years to assess the plans at all plants. Moreover, inspectors in 55
percent of the 5,000 plants nationwide did not document any HACCP
violations during fiscal year 2001. When we brought this information to
the attention of FSIS officials, they were surprised that so many plants
had no HACCP violations for an entire year.

snip...

2. USDA believes that the title of the report is misleading. We
disagree. We believe the title accurately reflects the concerns detailed
throughout the body of the report.

snip...

http://www.gao.gov/cgi-bin/getrpt?GAO-02-902

http://www.gao.gov/new.items/rc00255.pdf

FDA acknowledges that it has not yet identified and inspected
all firms subject to the ban” pg. 3 ;

http://www.gao.gov/new.items/d02183.pdf

The report concludes that “federal actions do not sufficiently ensure
that all
BSE-infected animals or products are kept out or that if BSE were found it
would be detected promptly and not spread to other cattle through animal
feed or enter the human food chain” italics added pg. 3 ;

http://www.gao.gov/new.items/d02183.pdf

and why does everybody conveniently ignore these findings;

Asante/Collinge et al, that BSE transmission to the 129-methionine genotype
can lead to an alternate phenotype that is indistinguishable from type 2
PrPSc,
the commonest _sporadic_ CJD;

http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm

To be published in the Proceedings of the
Fourth International Scientific Congress in
Fur Animal Production. Toronto, Canada,
August 21-28, 1988

Evidence That Transmissible Mink Encephalopathy
Results from Feeding Infected Cattle

R.F. Marsh* and G.R. Hartsough

•Department of Veterinary Science, University of Wisconsin-Madison, Madison,
Wisconsin 53706; and ^Emba/Creat Lakes Ranch Service, Thiensville,
Wisconsin 53092

ABSTRACT
Epidemiologic investigation of a new incidence of
transmissible mink encephalopathy (TME) in Stetsonville, Wisconsin
suggests that the disease may have resulted from feeding infected
cattle to mink. This observation is supported by the transmission of
a TME-like disease to experimentally inoculated cattle, and by the
recent report of a new bovine spongiform encephalopathy in
England.

INTRODUCTION ....snip...end


http://www.fda.gov/ohrms/dockets/dockets/03n0312/03N-0312_emc-000001.txt



TSS

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PORKER

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US Bioterrorism Act -
Administrative Detention, Establishment and Maintenance of Records
Purpose

This note sets out to update the contents of the Customer Information Notes 03/04, 02/30 and 02/23, which were issued on 18 February 2003, 23 October and 22 July respectively.

Background
The first two rules of this act relating to Registration of Food Facilities and Prior notice of Imported Food Shipments have already been published and comments invited. The commenting period closed on 4 April 2002.

We have received notification that the FDA are to work with customs over the requirements for prior notice of food shipments so that only one set of information will need to be provided to satisfy both customs and FDA requirements.A press notice is available on the US Food Import Notification System.

Recent Developments
The final two rules of the US Public Health and Bioterrorism Preparedness and Response Act were published on 9 May 2003. These relate to the Establishment and Maintenance of Records and Administrative Detention.

The FDA Bioterrorism site has been updated with these proposed regulations together with factsheets (see ‘Advice to Exporters’ for the address).

A live teleconference was held on the 7th May in the USA. This can be viewed by accessing the FDA website and selecting the link ‘Satellite Broadcast Video’ on the right hand side of the page.

Establishment and Maintenance of Records: key features
This requires both domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the United States to establish and maintain records. These records must be made available to the Secretary for Inspection 24HRS> to allow the Secretary to identify the immediate previous sources and immediate subsequent recipients of food, including its packaging, in order to address credible threats of serious adverse heath consequences (both to humans and animals).

FDA is describing the specific information a covered entity must keep, but not specify the form or type of system in which those records must be maintained.

For manufacturers, processors, packers, distributors, receivers, holders and importers of food (that is those other than transporters), the records would need to:

Identify the immediate non-transporter previous sources, whether foreign or domestic, of all foods received, including the name of the firm and the responsible individual; address; telephone number; fax number and email address, if available; type of food, including brand name and specific variety (e.g. Brand X Cheddar Cheese, not just cheese); date received; lot number or other identifier if available; quantity and type of packaging (e.g., 12oz bottles); and the name, address, telephone number and if available fax number and e-mail address of the transporter who brought it. The record must include information that is reasonably available to identify the specific source of each ingredient that was used to make every lot of finished product.

Identify the immediate non-transporter subsequent recipients of all foods released, including the name of the firm and the responsible individual; address; telephone number; fax number and email address, if available; type of food, including brand name and specific variety; date released; lot number or other identifier if available; quantity and type of packaging; and the name, address and telephone number and, if available, fax number and e-mail address of the transporter who transported the food from you. For transporters, the records for each food transported would have to include:

The name of the firm and the responsible individual who had the food before you and their address, telephone number, and, if available, fax number and e-mail address, and the date you receive it.
The name of the firm and responsible individual who had the food immediately after you and their address; telephone number, and, if available, fax number and e-mail address, and the date you delivered it.
The type of food, including brand name and specific variety; lot number or other identifier if available, quantity, and type of packaging.
Identification of each and every mode of transportation used (e.g., company truck, private carrier, rail, air etc.) and the individual responsible from when the food was first received until it was delivered.
The proposed rule requires that records are created when food is received, released or transported. Records for perishable foods not intended for processing into non-perishable foods, as well as records for animal food including pet food, would have to be retained for one year after from the date they were created. Records for all other foods would have to be retained for two years after the date they were created.

The records must be easily accessible. When the FDA has a reasonable belief that an article of food is adulterated and presents a serious threat, any records or other information to which the FDA has access must be available for inspection and photocopying or other means of reproduction within 24 hours if the request is made between 8:00am and 6:00pm, Monday to Friday, or within 8 hours if the request is made at any other time.

The following details are excluded from these regulations: recipes, financial data, pricing data, personnel data, research data and sales data. The definition of a recipe is the quantitative formula used in the manufacturing of the food product, but not the identity of the individual ingredients of the food.

Failure to maintain the required records or failure to make them available to the FDA will be a prohibited act. The Federal government has the power to bring a civil action in Federal Court to enjoin persons who commit a prohibited act; or the Federal government can bring a criminal action in Federal court to prosecute persons who commit a prohibited act.

The FDA rule will require all businesses, except small and very small businesses, to comply with the final rule 6 months from its publication in the Federal Register and that happened on DEC>09 / 04. Small businesses (fewer than 500 but more than 10 full-time equivalent employees) would have to comply within 12 months OR ON JUNE 06/06 from publication of the final rule, and very small businesses (10 or fewer full-time equivalent employees) would have to comply within 18 months from the publication of the final rule OR DEC> 09 /06.

NOTE FSIS rules is not as BAD as FDA rules.
 

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