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###### Department of Health and Human Services

###### Centers for Disease Control and Prevention

# AGENCY:

Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

# ACTION:

Final Notice.

# SUMMARY:

                        On January 21, 2009, CDC published a notice in the                         **Federal Register**                         (74 FR 3608) announcing its intent to rescind its February 4, 2004 order and subsequent amendments prohibiting the importation of birds and bird products from specified countries based on the threat that imports from such countries increases the risk that highly pathogenic avian influenza (HPAI) may be introduced into the United States. The U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) has implemented and continues to enforce regulations to prohibit or restrict the importation of birds, poultry, and unprocessed birds and poultry products from regions that have reported the presence of highly pathogenic avian influenza H5N1 in poultry. While USDA/APHIS actions are based primarily on protecting the U.S. commercial poultry industry from the introduction of highly pathogenic avian influenza H5N1, these actions have the added benefit of mitigating the risk of human exposure to the virus. Because the USDA/APHIS import restrictions adequately address risks to human health, HHS/CDC is announcing, in this Notice, its decision to lift its embargo against imports of birds and unprocessed bird products from those same countries. All of the bird embargoes that are currently in force under USDA regulations remain in effect. HHS/CDC will work closely with USDA/APHIS to monitor the international situation regarding HPAI H5N1 outbreaks and if human health risks are not adequately contained by USDA regulatory actions, CDC will take action to mitigate any human health risks associated with these outbreaks.                    

# DATE:

The decision is effective September 14, 2009.

# FOR FURTHER INFORMATION CONTACT:

Dr. Robert Mullan, Division of Global Migration and Quarantine, National Center for Preparedness, Detection, and Control of Infectious Diseases, Centers for Disease Control and Prevention, 1600 Clifton Road, NE., MS E-03, Atlanta, Georgia 30333; telephone 404-498-1600.

# SUPPLEMENTARY INFORMATION:

## Background

Since late 2003, highly pathogenic avian influenza (HPAI) has become established as a veterinary and human health threat throughout the world. As of April 1, 2009 HPAI has been confirmed by the World Organization for Animal Health (OIE) in birds from over 60 countries in Asia, Europe, and Africa. In addition, as of March 30, 2009, 413 human cases, including 256 deaths, have been confirmed by the World Health Organization (WHO). Birds imported into the United States from countries with HPAI could pose a risk for human infection or spread of virus to U.S. birds.

## USDA Actions

To protect the U.S. commercial poultry industry, USDA/APHIS has taken specific actions to reduce the threat of importing birds or products with HPAI.
    - USDA's authority for these actions is found at 9 CFR Parts 93 ,  94 , and  95 .
    - USDA/APHIS issued an interim final rule on February 4, 2004, and a final rule on July 20, 2005, providing restrictions on the importation of birds and unprocessed bird products from countries confirmed to have HPAI in commercial birds.
    - To date, USDA has placed import restrictions on 46 countries.
    - Import restrictions allow US-origin pet birds and performing birds to return to the United States following a 30-day quarantine at a USDA facility. Importations of processed bird products that have been rendered noninfectious are also allowed provided such products are accompanied by a USDA Veterinary Services (VS) permit and a government certification confirming that the products were treated according to USDA requirements.
    - Bird products that are potentially infectious may be imported for science and education purposes under a USDA/APHIS permit process, provided that the product can be safely transported.       ( print page 40825)      

## CDC Actions

On February 4, 2004, HHS/CDC issued an order to immediately ban the import of all birds (Class: Aves) from specified countries, subject to limited exemptions for returning pet birds of US origin and certain processed bird-derived products. HHS/CDC took this action because birds from these countries can potentially infect humans with HPAI. Countries affected by the February 4, 2004, order included Cambodia, Indonesia, Japan, Laos, People's Republic of China (including Hong Kong Special Administrative Region [SAR]), South Korea, Thailand, and Vietnam. This order was further amended on March 10, 2004, to lift the embargo of birds and bird products from the Hong Kong SAR because of the documented control of the outbreak there and the absence of HPAI cases in Hong Kong's domestic bird populations. Following the documentation of HPAI in commercial birds in additional countries, HHS/CDC amended the February 4, 2004, order to add these countries to its embargo: Malaysia on September 28, 2004; Kazakhstan, Romania, Russia, Turkey, and Ukraine on December 29, 2005; Nigeria on February 8, 2006; India on February 22, 2006; Egypt on February 27, 2006; Niger on March 2, 2006; Albania, Azerbaijan, Cameroon, and Burma (Myanmar) on March 15, 2006; Israel on March 20, 2006; Afghanistan on March 21, 2006; Jordan on March 29, 2006; Burkina Faso on April 10, 2006; Pakistan on April 10, 2006; Gaza, the West Bank, and Ivory Coast (Côte d'Ivoire) on April 28, 2006; Sudan on May 16, 2006; Djibouti on June 2, 2006; and Kuwait on February 28, 2007.

HHS/CDC has experienced practical and operational issues since the implementation of these orders. The orders
    - Duplicate the USDA/APHIS rule and thus do not provide any additional protection of the public's health;
    - Cause confusion at ports of entry regarding which agency has primary authority to respond;
    - Give the appearance of a lack of coordinated action by the U.S. government, and
    - May interfere with the importation of products for laboratory evaluation, epidemiologic assessment, and vaccine distribution and research.

                    Thus, on January 21, 2009, CDC published a notice with a 30-day comment period in the                     **Federal Register**                     (74 FR 3608) in which it announced its intention to rescind the February 4, 2004, order and all subsequent orders prohibiting the importation of birds and bird products from specified countries.                

## Public Comments Received and CDC Responses

CDC received three comments from the public in response to its January 21, 2009 Notice. Two commenters opposed CDC's proposal to rescind its bird embargo and one commenter commended CDC on its recognition that USDA's ban also protects human health.

*Public Comment #1:*                     The first comment opposing the plan for CDC to rescind its bird embargo cited three concerns, as follows:                

1. The USDA and CDC prohibitions have been part of a well-coordinated federal response to the avian influenza threat, and there is no need to change these practices.

2. The USDA does not have the mandate to protect human health from the introduction of pathogens into the United States, and CDC does.

3. Rescinding the CDC prohibitions might have the undesirable effect of reducing the public's understanding of human health concerns, including avian influenza, associated with the importation of birds and bird products into the United States.

*CDC Response:*                     While the USDA/APHIS rule is based primarily on protecting the U.S. commercial poultry industry from introduction of HPAI H5N1, it has the added benefit of mitigating the risk of human exposure to the virus. Through contacts with international veterinary authorities and trade relationships with countries of concern, USDA/APHIS is able to quickly assess import risk and subsequently implement importation restrictions on affected countries. By working in close collaboration with USDA/APHIS, CDC is confident that their actions before issuing new bird import orders are sufficient to protect public health.                

As the nation's lead agency for human health, HHS/CDC will ensure mitigation of the human health risks from HPAI and other animal influenza viruses that pose a risk to human health while also demonstrating a coordinated and efficient federal approach to managing risks from imported birds and unprocessed bird products. HHS/CDC will also take action if future USDA/APHIS restrictions do not adequately address the public health risk from HPAI or other influenza viruses in animals.

HHS/CDC will take the following steps to ensure the human health threat of HPAI H5N1 continues to be prevented:

1. To enforce USDA's importation embargo, CDC staff at the 20 U.S. Quarantine Stations will continue working closely with other federal agencies at ports of entry, such as USDA, the Department of Homeland Security (DHS), and the U.S. Fish and Wildlife Service (FWS) of the Department of the Interior (DoI).

2. CDC staff will closely follow the international situation regarding HPAI outbreaks and spread through review of information from its internal surveillance systems, World Health Organization Influenza Collaborating Centers, CDC's USDA liaison officer, the United Nations Food and Agriculture Organization, and the World Organization for Animal Health.

3. CDC staff will continue to monitor the World Organizations for Animal Health (OIE) and USDA/APHIS actions toward countries in which HPAI has been established in commercial birds to ascertain that they are consistent and make an assessment if actions taken mitigate the human health risk to the United States. If the review process identifies human health risks that are not adequately contained by USDA/APHIS actions, HHS/CDC will implement additional importation restrictions for birds and unprocessed bird products. For example, if human cases of HPAI were reported in a country with no official confirmation of avian cases (that would normally trigger a USDA ban), HHS/CDC could implement restrictions on an emergency basis.

                    4. CDC staff will post a link to all USDA/APHIS restrictions on its Web site (                    *http://www.cdc.gov/​flu/​avian/​outbreaks/​embargo.htm*).                

5. CDC and USDA will continue to collaborate on guidelines and protocols to ensure a timely and coordinated response to an HPAI outbreak should it occur in the United States. In 2005-2006 the agencies worked together with other federal agencies on the USDA Playbook for Avian Influenza, a protocol that defines each agency's roles and responsibilities in response to H5N1 in the United States.

                    6. CDC staff will closely monitor human cases of HPAI and human infections with other novel influenza strains in other countries. If the review process identifies clearly that risks to human health could be further mitigated by an importation ban on birds and bird products coming from a particular country, HHS/CDC will implement additional importation restrictions for birds and unprocessed bird products. For example, if human illnesses and/or deaths from infection with a novel strain of influenza also shown to be                           ( print page 40826)                        circulating in birds were reported in a country with no official confirmation of avian cases (that would normally trigger a USDA ban), HHS/CDC could implement restrictions on an emergency basis.                

*Public Comment #2:*                     The second comment was not specific for HPAI, but addressed general concerns about potentially zoonotic diseases associated with wild birds. The commenter urged CDC to reconsider rescinding this order with respect to live birds and to review the disease risks created by these bird imports to protect people from dangerous infectious diseases.                

*CDC Response:*                     The current embargo on birds and bird products from countries that have had HPAI identified in poultry is very specific and does not cover all potentially zoonotic diseases from imported wild birds. Therefore, rescinding the current order would have neither an adverse nor a positive affect on the zoonotic risks of importing wild birds.                

*Public Comment #3:*                     The third comment was in support of CDC's rescission of its bird embargo.                

*CDC Response:*                     As stated above, CDC will continue to work closely with USDA and other human and animal health partners to monitor the situation with HPAI in both birds and people to protect both animal and human health in the United States.                

In summary, HHS/CDC believes that the actions taken to date by USDA/APHIS adequately mitigate the human health risks of HPAI associated with birds and unprocessed bird products imported from the countries of concern. HHS/CDC plans to mitigate any future human health risks that are not adequately addressed by USDA/APHIS regulations, thus ensuring a strong coordinated federal response. Therefore, the HHS/CDC order of February 4, 2004, and its subsequent amendments are no longer needed.

## Action

Therefore, effective September 14, 2009, HHS/CDC is rescinding its February 4, 2004, order and all amendments from the following dates: March 10, 2004; September 28, 2004; December 29, 2005; February 8, 2006; February 22, 2006; February 27, 2006; March 2, 2006; March 15, 2006; March 20, 2006; March 21, 2006; March 29, 2006; April 10, 2006;  April 28, 2006; May 16, 2006; June 2, 2006; and February 28, 2007.

Dated: August 5, 2009.

James Seligman,

Chief Information Officer,  Centers for Disease Control   and Prevention.

[FR Doc. E9-19453 Filed 8-12-09; 8:45 am]

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