Saturday, August 12, 2017

Rules of Practice Governing Formal Adjudicatory Proceedings Instituted by the Secretary Under Various Statutes COOL

Canadian Meat Inspection System Questioned by USDA Report 

By Greg Henderson August 11, 2017 | 8:30 am EDT 

inspection and sanitation problems during Canadian audit. 

FSIS finds "systemic" inspection and sanitation problems during Canadian audit. 

A recent U.S. Department of Agriculture audit of Canada’s meat, poultry and egg inspection systems found “systemic” inspection and sanitation problems which raise “significant questions about the Canadian system.”

The report is from a series of “onsite equivalence verification” audits conducted by USDA’s Food Safety and Inspection Service (FSIS) last September at seven Canadian slaughteer and processing facilities. The most “significant” concern, FSIS said, was the Canadian inspectors were not conducting carcass-by-carcass inspections for contaminations by “feces, milk or ingesta” before stamping the carcasses as inspected. Such contamination is a primary pathway for pathogen transmission, including E. coli.

"Post-mortem inspection procedures that do not ensure carcass-by-carcass inspection . . . raise significant questions about the Canadian system," FSIS officials wrote in the audit.

The audits were conducted in September 2016 in slaughterhouses in Alberta, British Columbia, Ontario and Quebec and shared with the Canadian Food Inspection Agency in April.

According to the report, the U.S. rejected a total of 1.7 million pounds of Canadian meat and poultry at the port of entry, of which about 130,000 pounds were found to have been contaminated with fecal matter, ingesta or other pathogens. A total of about 4.8 billion pounds of meat and poultry were exported to the U.S. from Canada during that time period. ...snip..see;


Rules of Practice Governing Formal Adjudicatory Proceedings Instituted by the Secretary Under Various Statutes

A Rule by the Agriculture Department on 08/09/2017

AGENCY: Office of the Secretary, USDA.

ACTION: Final rule.

SUMMARY: This final rule amends the scope and applicability of the U.S. Department of Agriculture's (USDA) uniform rules of practice governing adjudicatory proceedings to include actions initiated under subtitles B and D of the Agricultural Marketing Act of 1946, as amended (1946 Act).

DATES: Effective August 9, 2017.

FOR FURTHER INFORMATION CONTACT: Michael Lynch, Director; Livestock, Poultry, and Grain Market News Division; Livestock, Poultry, and Seed Program; AMS, USDA, Room 2619-S, STOP 0252; 1400 Independence Avenue SW., Washington, DC 20250-0251; telephone (202) 720-4868; fax (202) 690-3732; or email Michael.Lynch@ams.usda.gov.

SUPPLEMENTARY INFORMATION: USDA's uniform rules of practice (7 CFR part 1, subpart H), which govern the conduct of adjudicatory proceedings under numerous statutes, have been in effect since February 1, 1977. Under this final rule, subtitles B (Livestock Mandatory Reporting) and D (Country of Origin Labeling) of the 1946 Act (7 U.S.C. 1621 et seq.) are governed by these uniform procedures to ensure consistency and uniformity in the conduct of USDA's administrative activities.

Subtitle B (7 U.S.C. 1635-1636i) of the 1946 Act authorizes the Secretary, having given notice and an opportunity for hearing, to assess civil penalties (fines) against any packer (as defined therein) or other person that violates Livestock Mandatory Reporting regulations (7 U.S.C. 1636b). Each civil penalty assessed by the Secretary may be no more than $10,000 for each violation, as adjusted by 7 CFR 3.91.

Subtitle D (7 U.S.C. 1638-1638d) of the 1946 Act authorizes the Secretary to take enforcement actions, including civil penalties (fines), against a retailer (as defined by the Perishable Agricultural Commodities Act (7 U.S.C. 499a(b)(11)) or any person engaged in the business of supplying a covered commodity to a retailer, that is determined, after providing notice and an opportunity for a hearing before the Secretary with respect to the violation, not to have made good faith effort to comply with Country of Origin Labeling regulations and has continued to willfully violate these regulations.

This action has been reviewed in accordance with the requirements of Executive Order 13175, Consultation and Coordination with Indian Tribal Governments. The review reveals this action would not have substantial and direct effects on Tribal governments and would not have significant Tribal implications.

This rule does not meet the definition of a significant regulatory action contained in section 3(f) of Executive Order 12866, and is not subject to review by the Office of Management and Budget (OMB). Additionally, because this rule does not meet the definition of a significant regulatory action it does not trigger the requirements contained in Executive Order 13771. See OMB's Memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017 titled `Reducing Regulation and Controlling Regulatory Costs' ” (February 2, 2017).

Pursuant to 5 U.S.C. 553, notice of proposed rulemaking and opportunity for comment are not required for this rule regarding agency procedure or practice, and it may be made effective less than 30 days after publication in the Federal Register.

In addition, under 5 U.S.C. 804, this action is not subject to congressional review under the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121).

Finally, this action is not a rule as defined by the Regulatory Flexibility Act (5 U.S.C. 601-612) and is thus exempt from the provisions of that Act.

This rule contains no information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

List of Subjects in 7 CFR Part 1 Administrative practice and procedure Antitrust Claims Cooperatives Courts Equal access to justice Fraud Freedom of information Government employees Indemnity payments Lawyers Motion pictures Penalties Privacy For the reasons set forth in the preamble, 7 CFR part 1 is amended as follows:

PART 1—ADMINISTRATIVE REGULATIONS 1. The authority citation for part 1 continues to read as follows:

Authority: 5 U.S.C. 301, unless otherwise noted.

2. The authority citation for subpart H is revised to read as follows:

Authority: 5 U.S.C. 301; 7 U.S.C 61, 87e, 228, 268, 499o, 608c(14), 1592, 1624(b), 1636b, 1638b, 2151, 2279e, 2621, 2714, 2908, 3812, 4610, 4815, 4910, 6009, 6107, 6207, 6307, 6411, 6519, 6520, 6808, 7107, 7734, 8313; 15 U.S.C. 1828; 16 U.S.C. 620d, 1540(f), 3373; 21 U.S.C. 104, 111, 117, 120, 122, 127, 134e, 134f, 135a, 154, 463(b), 621, 1043; 30 U.S.C. 185(o)(1); 43 U.S.C. 1740; 7 CFR 2.27, 2.35.

3. Amend § 1.131 in paragraph (a) by adding in alphabetical order an entry for “Agricultural Marketing Act of 1946” to read as follows:

§ 1.131 Scope and applicability of this subpart. (a) * * *

Agricultural Marketing Act of 1946, as amended, section 253 (7 U.S.C. 1636b) and section 283 (7 U.S.C. 1638b).

* * * * * Dated: August 4, 2017.

Sonny Perdue,

Secretary.

[FR Doc. 2017-16786 Filed 8-8-17; 8:45 am]

BILLING CODE 3410-02-P



FINAL REPORT OF AN AUDIT CONDUCTED IN CANADA

September 12-30, 2016

EVALUATING THE FOOD SAFETY SYSTEM GOVERNING

THE PRODUCTION OF MEAT, POULTRY, AND EGG PRODUCTS

EXPORTED TO

THE UNITED STATES OF AMERICA 

Executive Summary

This report describes the outcome of an onsite equivalence verification audit conducted by the Food Safety and Inspection Service (FSIS) from September 12 - 30, 2016, to determine whether Canada’s food safety inspection system governing the production of meat, poultry, and egg products remains equivalent to that of the United States with the ability to produce products that are safe, wholesome, unadulterated, and properly labeled. Canada is eligible to export raw and processed meat, raw and processed poultry, and egg products to the United States.

The audit focused on six main system equivalence components: 

(1) Government Oversight (e.g., Organization and Administration); 

(2) Government Statutory Authority and Food Safety and Other Consumer Protection Regulations (e.g., Inspection System Operation, Product Standards and Labeling, and Humane Handling); 

(3) Government Sanitation; 

(4) Government Hazard Analysis and Critical Control Points (HACCP) System; 

(5) Government Chemical Residue Testing Programs; and 

(6) Government Microbiological Testing Programs. 

In addition, the FSIS auditors verified that the corrective actions proffered by the Central Competent Authority (CCA) in response to the 2014 FSIS audit findings had indeed been implemented. 

The FSIS auditors reviewed management, supervision, and administrative functions at the CCA headquarters, three regional offices, seven slaughter and processing establishments (two swine, two bovine, two poultry, one bovine/caprine), four processing-only establishments, one egg processing facility, one cold storage facility, and two laboratories to verify that the national system of inspection, verification, and enforcement is being implemented as required to maintain equivalence.

The FSIS auditors identified the following systemic findings and isolated findings: Government Statutory Authority and Food Safety and Other Consumer Protection Regulations

• The government inspectors may not have been conducting complete carcass-by-carcass post-mortem inspection to ensure freedom from contamination with feces, milk, or ingesta for reconditioned carcasses prior to applying mark of inspection.

Government Sanitation

• In 11 of 13 establishments audited, FSIS observed findings related to requirements of Sanitation Performance Standards (SPS). SPS findings are noted in their respective individual establishment checklist provided in Appendix A of this report.

Government HACCP System

• In two establishments, HACCP verification records did not include the result of the verification activities. Isolated HACCP findings are noted in their respective individual establishment checklist provided in Appendix A of this report.

During the audit exit meeting, the CCA committed to begin addressing the preliminary findings as presented. FSIS will evaluate the adequacy of the CCA’s proposed corrective actions once received.

TABLE OF CONTENTS

SNIP...see full report ; 


FINAL REPORT OF AN AUDIT CONDUCTED IN

CANADA

May 28 - June 13, 2014

EVALUATING THE FOOD SAFETY SYSTEM GOVERNING

THE PRODUCTION OF MEAT, POULTRY, AND EGGPRODUCTS

INTENDED FOR EXPORT TO

THE UNITED STATES OF AMERICA


SPONTANEOUS ATYPICAL BOVINE SPONGIFORM ENCEPHALOPATHY

***Moreover, sporadic disease has never been observed in breeding colonies or primate research laboratories, most notably among hundreds of animals over several decades of study at the National Institutes of Health25, and in nearly twenty older animals continuously housed in our own facility.***


O.05: Transmission of prions to primates after extended silent incubation periods: Implications for BSE and scrapie risk assessment in human populations
 
Emmanuel Comoy, Jacqueline Mikol, Valerie Durand, Sophie Luccantoni, Evelyne Correia, Nathalie Lescoutra, Capucine Dehen, and Jean-Philippe Deslys Atomic Energy Commission; Fontenay-aux-Roses, France
 
Prion diseases (PD) are the unique neurodegenerative proteinopathies reputed to be transmissible under field conditions since decades. The transmission of Bovine Spongiform Encephalopathy (BSE) to humans evidenced that an animal PD might be zoonotic under appropriate conditions. Contrarily, in the absence of obvious (epidemiological or experimental) elements supporting a transmission or genetic predispositions, PD, like the other proteinopathies, are reputed to occur spontaneously (atpical animal prion strains, sporadic CJD summing 80% of human prion cases). Non-human primate models provided the first evidences supporting the transmissibiity of human prion strains and the zoonotic potential of BSE. Among them, cynomolgus macaques brought major information for BSE risk assessment for human health (Chen, 2014), according to their phylogenetic proximity to humans and extended lifetime. We used this model to assess the zoonotic potential of other animal PD from bovine, ovine and cervid origins even after very long silent incubation periods.
 
*** We recently observed the direct transmission of a natural classical scrapie isolate to macaque after a 10-year silent incubation period,
 
***with features similar to some reported for human cases of sporadic CJD, albeit requiring fourfold long incubation than BSE. Scrapie, as recently evoked in humanized mice (Cassard, 2014),
 
***is the third potentially zoonotic PD (with BSE and L-type BSE),
 
***thus questioning the origin of human sporadic cases. We will present an updated panorama of our different transmission studies and discuss the implications of such extended incubation periods on risk assessment of animal PD for human health.
 
===============
 
***thus questioning the origin of human sporadic cases***
 
===============
 
***our findings suggest that possible transmission risk of H-type BSE to sheep and human. Bioassay will be required to determine whether the PMCA products are infectious to these animals.
 
==============
 
 
 Transmission data also revealed that several scrapie prions propagate in HuPrP-Tg mice with efficiency comparable to that of cattle BSE. While the efficiency of transmission at primary passage was low, subsequent passages resulted in a highly virulent prion disease in both Met129 and Val129 mice. Transmission of the different scrapie isolates in these mice leads to the emergence of prion strain phenotypes that showed similar characteristics to those displayed by MM1 or VV2 sCJD prion. These results demonstrate that scrapie prions have a zoonotic potential and raise new questions about the possible link between animal and human prions.
 
 
Title: Transmission of scrapie prions to primate after an extended silent incubation period) 

*** In complement to the recent demonstration that humanized mice are susceptible to scrapie, we report here the first observation of direct transmission of a natural classical scrapie isolate to a macaque after a 10-year incubation period. Neuropathologic examination revealed all of the features of a prion disease: spongiform change, neuronal loss, and accumulation of PrPres throughout the CNS. 

*** This observation strengthens the questioning of the harmlessness of scrapie to humans, at a time when protective measures for human and animal health are being dismantled and reduced as c-BSE is considered controlled and being eradicated. 

*** Our results underscore the importance of precautionary and protective measures and the necessity for long-term experimental transmission studies to assess the zoonotic potential of other animal prion strains. 


MONDAY, MAY 29, 2017 

*** Canada CCA optimistic over potential for revisions to OIE criteria for BSE negligible risk

 
TUESDAY, AUGUST 8, 2017 

*** Concurrence With OIE Risk Designations for Bovine Spongiform Encephalopathy [Docket No. APHIS-2016-0092]


THURSDAY, JUNE 22, 2017 

*** World Organisation for Animal Health (OIE) to establish liaison office in College Station, Texas


WEDNESDAY, JULY 26, 2017 

*** APHIS USDA Emerging Animal Disease Preparedness and Response Plan July 2017


TUESDAY, JULY 18, 2017 

*** USDA announces Alabama case of Bovine Spongiform Encephalopathy Alabama


THURSDAY, JULY 20, 2017 

*** USDA OIE Alabama Atypical L-type BASE Bovine Spongiform Encephalopathy BSE animal feeds for ruminants rule, 21 CFR 589.200


SUNDAY, JULY 23, 2017

atypical L-type BASE Bovine Amyloidotic Spongiform Encephalopathy BSE TSE PRION


SUNDAY, JULY 23, 2017

Experimental Infection of Cattle With a Novel Prion Derived From Atypical H-Type Bovine Spongiform Encephalopathy


Saturday, July 23, 2016

BOVINE SPONGIFORM ENCEPHALOPATHY BSE TSE PRION SURVEILLANCE, TESTING, AND SRM REMOVAL UNITED STATE OF AMERICA UPDATE JULY 2016


Tuesday, July 26, 2016

Atypical Bovine Spongiform Encephalopathy BSE TSE Prion UPDATE JULY 2016


Monday, June 20, 2016

Specified Risk Materials SRMs BSE TSE Prion Program


THURSDAY, JULY 13, 2017 

EFSA BSE Sixty cases of mad cow disease since 2001 breached feed ban likely the cause 

Scientists investigate origin of isolated BSE cases


SUNDAY, AUGUST 06, 2017 

USA Chronic Wasting Disease CWD TSE Prion Emergency Response Plan Singeltary et al 


MONDAY, JULY 17, 2017 

National Scrapie Eradication Program May 2017 Monthly Report Fiscal Year 2017 


SUNDAY, JULY 30, 2017 

Do we need to explain the occurrence of atypical scrapie?


SATURDAY, JULY 29, 2017

Risk Advisory Opinion: Potential Human Health Risks from Chronic Wasting Disease CFIA, PHAC, HC (HPFB and FNIHB), INAC, Parks Canada, ECCC and AAFC


PRION 2017 DECIPHERING NEURODEGENERATIVE DISORDERS 

 Subject: PRION 2017 CONFERENCE DECIPHERING NEURODEGENERATIVE DISORDERS VIDEO

PRION 2017 CONFERENCE DECIPHERING NEURODEGENERATIVE DISORDERS

PRION 2017 CONFERENCE VIDEO



Chronic Wasting Disease CWD TSE Prion to Humans, who makes that final call, when, or, has it already happened?

TUESDAY, JUNE 13, 2017

PRION 2017 CONFERENCE ABSTRACT First evidence of intracranial and peroral transmission of Chronic Wasting Disease (CWD) into Cynomolgus macaques: a work in progress


TUESDAY, JULY 04, 2017

*** PRION 2017 CONFERENCE ABSTRACTS ON CHRONIC WASTING DISEASE CWD TSE PRION ***


TUESDAY, JULY 18, 2017 

MINK FARMING USA TRANSMISSIBLE MINK ENCEPHALOPATHY TSE PRION DISEASE SURVEILLANCE AND TESTING



THURSDAY, AUGUST 10, 2017 

Minimise transmission risk of CJD and vCJD in healthcare settings Updated 10 August 2017


FRIDAY, AUGUST 11, 2017 

Infectivity in bone marrow from sporadic CJD patients

Bioassays in transgenic mice expressing the human prion protein revealed the presence of unexpectedly high levels of infectivity in the bone marrow from seven out of eight sCJD cases. These findings may explain the presence of blood-borne infectivity in sCJD patients. They also suggest that the distribution of prion infectivity in peripheral tissues in sCJD patients could be wider than currently believed, with potential implications for the iatrogenic transmission risk of this disease. 


National Prion Center could lose all funding just as concern about CWD jumping to humans rises

SATURDAY, JULY 15, 2017 

National Prion Center could lose all funding just as concern about CWD jumping to humans rises


Terry S. Singeltary Sr.

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