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WOAH: Biological Standards

Standards for Comment 

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The Biological Commission helps ensure the Manual of Diagnostic Tests for

Terrestrial Animals (Terrestrial Manual) reflects current scientific information. The

Terrestrial Manual develops international standards for laboratory diagnostic tests

and vaccines for animal diseases.

APHIS provides the draft standards below and invites stakeholders to comment.

To provide comments:

1. Download the files by clicking the links below that correspond to the standards

you wish to review.

2. Edit the specific text you are commenting on by proposing text changes (that

is, edit the text the way you believe it should read) using “Track Changes” in

Microsoft Word.

3. Add a “comment” with the supporting scientific or other rationale for each of

your proposed text changes using “Track Changes” in Microsoft Word.

4. Submit your proposed changes to usa.oie.iahs@usda.gov no later than

Monday, April 15, 2024.
The "USA Comments Submitted to WOAH" will be uploaded promptly in the tables

below.

Standards Proposed for Adoption (Part A)

Chapters Proposed for Adoption, February 2024 USA Comments

Submitted

Work Programme

Chapter 1.1.05. Quality Management in Veterinary Testing

Laboratories

Chapter 1.1.09. Tests for Sterility and Freedom from

Contamination of Biological Materials Intended for Veterinary

Use

Chapter 2.2.04. Measurement Uncertainty

Chapter 2.2.06. Selection and Use of Reference Samples and

Panels

Chapter 3.1.5. Crimean–Congo Haemorrhagic Fever

Chapter 3.3.06. Avian Tuberculosis

Chapter 3.4.01. Bovine Anaplasmosis

Chapter 3.4.07. Bovine Viral Diarrhoea

Chapter 3.4.12. Lumpy Skin Disease

Chapter 3.6.09. Equine Rhinopneumonitis (Infection with

Varicellovirus equidalpha1)

Chapter 3.8.01. Border Disease

Chapter 3.8.12. Sheep Pox and Goat Pox

Chapter 3.9.1. African Swine Fever

Template for curriculum vitae for Reference Laboratory experts

Registration of Genelix Diagnostic Kit for ASFV 

Registration of Sentinel for Diagnostic kit for ASFV 

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Previous Biological Chapters Proposed Drafts and Comments

September 2023
Chapters Proposed for Adoption,

September 2023 USA Comments Submitted

Chapter 1.1.5. Quality management in

veterinary testing laboratories (218.49 KB) No comments submitted

Chapter 1.1.9. Tests for sterility and freedom

from contamination of biological materials

(399.25 KB)

No comments submitted 

Chapter 2.2.4 Measurement Uncertainty

(130.32 KB)

Chapter 2.2.4 Measurement

Uncertainty (125.16 KB)

Chapter 2.2.6. Selection and use of reference

samples and panels (221.44 KB)

Chapter 2.2.6. Selection and use of

reference samples and panels

(213.02 KB)

Chapter 3.1.5. Crimean–Congo haemorrhagic

fever (32.97 KB)

Chapter 3.1.5. Crimean–Congo

haemorrhagic fever (42.99 KB)

Chapter 3.3.6. Avian tuberculosis (209.95 KB) No comments submitted 

Chapter 3.4.1. Bovine anaplasmosis (343.06

KB) No comments submitted 

Chapter 3.4.7. Bovine viral diarrhoea (245.36

KB) No comments submitted 

Chapter 3.4.12. Lumpy Skin Disease (280.04

KB) No comments submitted 

Chapter 3.6.9. Equine rhinopneumonitis

(infection with equid herpesvirus-1) (313.56

KB)

No comments submitted 

Chapter 3.8.1. Border disease (138.99 KB) No comments submitted 

Chapter 3.8.12. Sheep pox and goat pox

(148.5 KB)

Chapter 3.8.12. Sheep pox and goat

pox (139.17 KB)

Chapter 3.9.1. African swine fever (276.13 KB) Chapter 3.9.1. African swine fever

(281.69 KB)

Chapter 3.10.4. Infection with Campylobacter

jejuni and C. coli (243.82 KB) No comments submitted 

Chapter 3.10.8. Toxoplasmosis (127.1 KB) No comments submitted 

February 2023
Chapters Proposed for Adoption,

February 2023  USA Comments Submitted

Glossary (33.87 KB) No comments submitted

Chapter 1.1.6. Principles Methods of

Validation of Diagnostic Assays (395.28 KB) No comments submitted 

Chapter 1.0.10. Vaccine Banks (65.92 KB) No comments submitted 

Chapter 3.01.01. Anthrax (75.28 KB) No comments submitted 

Chapter 3.01.5. Crimean–Congo

Haemorrhagic Fever Virus (92.93 KB) No comments submitted 

Chapter 3.01.18. Rabies (137.5 KB) No comments submitted 

Chapter 3.01.19. Rift Valley Fever (119.83 KB) No comments submitted 

Chapter 3.01.22. Trichinellosis (97.67 KB) No comments submitted 

Chapter 3.02.02. American Foulbrood of

Honey Bees (27.32 MB)

Chapter 3.02.02. American

Foulbrood of Honey Bees (24.96 MB)

Chapter 3.02.03. European Foulbrood of

Honey Bees (3.94 MB)

Chapter 3.02.03. European

Foulbrood of Honey Bees (3.94 MB)

Chapter 3.03.10. Fowlpox (66.76 KB) No comments submitted 

Chapter 3.03.13 Marek’s Disease (92.02 KB) Chapter 3.03.13 Marek’s Disease

(91.14 KB)

Chapter 3.04.12. Lumpy Skin Disease (89.64

KB) No comments submitted 

Chapter 3.07.02. Rabbit Haemorrhagic

Disease (103.14 KB)

Chapter 3.07.02. Rabbit

Haemorrhagic Disease (107.66 KB)

Chapter 3.09.07. Influenza A Virus of Swine

(113.39 KB)

Chapter 3.09.07. Influenza A Virus of

Swine (117.57 KB)

Chapter 3.10.01. Bunyaviral Diseases (109.25

KB) No comments submitted 

Biological Standards Commission Reports

Current Report

Report of the Meeting of the WOAH Biological Standards Commission, February

2024
Previous Reports

Report of the Meeting of the WOAH Biological Standards Commission,

September 2023 (woah.org)

Report of the Meeting of the WOAH Biological Standards Commission, February

2023

Report of the Meeting of the OIE Biological Standards Commission, February

2022 (408.35 KB)

Report of the Meeting of the OIE Biological Standards Commission, September

2021 (3.35 MB)

Report of the Meeting of the OIE Biological Standards Commission, Part A,

February 2021 (500.17 KB)

Report of the Meeting of the OIE Biological Standards Commission, Part B,

February 2021 (983.58 KB)