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2003年12月12日之后，美国《反生物恐怖法》的305和307条款生效。中国出口企业如果不遵照执行，将会被拒于美国市场门外！
北京市立闻达信息资源开发有限公司致力于商业信息服务领域，我们与美国昆腾姆-梅迪亚有限公司（America Quantum Media LLC
）有着长期稳定而密切的业务合作关系，此次，本公司急国内企业之所急，特与该公司一起，推出FDA代理快速注册以及其他相关服务。
美国《反生物恐怖法》305条款
美国《2002年公共健康安全与生物恐怖主义预防和应急法》要求所有在美国国内和国外从事食品制造、加工、包装、存储、运输、配发、接收、储存及进口，供给人类或动物食用的厂家，必须在2003年12月12日之前向美国FDA（联邦食品和药品管理局）登记注册。
哪些厂家必须登记注册？
美国国内厂家，无论其产品是否直接进入美国州际贸易，都须注册。从事食品制造、加工、包装、存储、运输、配发、接收、储存，并出口到美国，供给人类或动物食用的外国厂家，必须向美国FDA注册。
如果厂家没有进行注册将会有什么后果？
如果美国国内及国外厂家没有根据条例要求注册、更新信息，或取消注册，这是美国《联邦食品、药物和化妆品法》所明令禁止的行为。联邦政府可以根据民事法，要求联邦法院禁止该厂家的负责人进入美国，或将厂家负责人违反条例的行为视作犯罪活动而受到联邦法院起诉。如果国外厂家没有按要求进行注册，从国外厂家出口到美国的食品货物将在港口入境时被海关扣押，直到FDA、海关或国土安全局确认注册完成后才放行。此过程中所有费用由出口商承担，并承担金额的罚款。
哪些厂家可以免予注册？
可以免予注册的厂家有：农场、食品零售组织、餐馆、为消费者准备或直接提供食品的非赢利性组织、不从事加工处理工作的渔业捕捞组织，以及美国农业部独家管理的厂家。
如何注册？
外国厂家必须指定一家美国代理商进行代理注册，该代理商必须在美国拥有实际的商业运营场所。
什么是美国代理商？
外国厂家必须指定一家在美国的代理商进行代理注册。美国代理商就是在美国拥有实际商业活动场所的个人或机构，外国厂家指定其为代理商办理在美国的注册事宜。代理商将扮演一个在FDA与外国厂家间的联系纽带。FDA将视代理商为外国厂家的全权代表，并且将由美国代理商递交的资料视作为由外国厂家亲自递交的资料。一个厂家只能指定一家美国注册代理。
注册号码的意义？
厂家通过注册后可获得一个注册号码。注册号码意味着厂家业主通过注册FDA的形式已经遵守了该条例。转让注册码不会被FDA批准，并且不会认可其厂家及其所产货品。
办理注册所需时间？
由我们代理注册的厂商，如果所提供的信息完整准确，将在5个工作日内成功注册，获得FDA配给的注册号码。其后，厂家将收到FDA发出的注册备案文件。 |
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（附：美国联邦食品和药品管理局关于《反生物恐怖主义法》305条款注册的英文说明）
Overview & Background
The Law:
The
Public Health Security and Bioterrorism Preparedness and Response Act
of 2002 (the Bioterrorism Act) requires domestic and foreign
facilities that manufacture, process, pack, or hold food for human or
animal consumption in the United States to register with the FDA by December
12, 2003.
Who must register?
Owners,
operators, or agents in charge of domestic or foreign facilities that
manufacture/process, pack, or hold food for human or animal
consumption in the United States are required to register the facility
with the FDA. Domestic facilities are
required to register whether or not food from the facility enters
interstate commerce. Foreign facilities that
manufacture/process, pack, or hold food also are required to register
if the food is exported to the United States.
Examples of
FDA-regulated Foods
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Food
and food additives for man or animals
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Dietary
supplements and dietary ingredients
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Infant
formula
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Beverages
(including alcoholic beverages and bottled water)
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Fruits
and vegetables
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Fish
and seafood
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Dairy
products and shell eggs
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Raw
agricultural commodities for use as food or components of food
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Canned
foods
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Live
food animals
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Bakery
goods, snack food, and candy
What happens if a
facility does not register?
Failure
of a domestic or foreign facility to register, update required
elements, or cancel its registration in accordance with this
regulation is a prohibited act under the Federal Food, Drug, and
Cosmetic Act. The Federal government can bring a civil action to ask a
Federal court to enjoin persons who commit a prohibited act, or it can
bring a criminal action in Federal court to prosecute persons who are
responsible for the commission of a prohibited act. If a foreign
facility is required to register but fails to do so, food from that
foreign facility that is offered for import into the U.S. is subject
to being held within the port of entry for the article unless
otherwise directed by FDA or the Bureau of Customs and Border
Protection (CBP).
What facilities are
exempted from registration?
Exempt
from registration are farms; retail food establishments; restaurants;
non-profit establishments that prepare food for, or serve food
directly to, consumers; fishing vessels not engaged in processing [as
defined in 21 CFR 123.3 (k)]; and facilities regulated exclusively
throughout the entire facility by the U.S. Department of Agriculture.
How can a facility
register?
Registrants
must use Form 3537 to register or update a registration. A
foreign facility must designate a U.S. agent, who must live or
maintain a place of business in the U.S. and be physically present in
the U.S., for purposes of registration.
What Information Is
Required?
-
Name,
physical address, phone number of the facility
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Same information for the parent
company, if the facility is a subsidiary
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All
trade names the facility uses
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Food product categories
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A statement certifying that the
information submitted is true and accurate and submitter is
authorized to register the facility
-
Name and contact information of the
person submitting the certification statement
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Name of foreign facility's U.S. agent
and the agent's contact information
-
Emergency contact information
What is a U.S.
Agent?
A
foreign facility must designate a U.S. agent for purposes of
registration. A U.S. agent means a person
residing or maintaining a place of business in the U.S. whom a foreign
facility designates as its U.S. agent for purposes of the registration
regulation. The U.S. agent acts as a communications link between FDA
and the foreign facility. FDA will treat representations by the U.S.
agent as those of the foreign facility, and will consider information
or documents provided to the U.S. agent equivalent to providing the
information or documents to the foreign facility. Only one person can
be designated as the “U.S. Agent”.
What if the
submitted registration information changes?
When
a required element of a facility's registration information changes,
e.g., change of operator, agent in charge, or U.S. agent, the owner,
operator, or agent in charge, or an individual authorized by one of
them, must submit an update to the facility's registration within 60
days of the change.
What if a new owner
acquires an already-registered facility?
The
former owner must cancel the facility's registration within 60 days of
the change (using Form 3537a), and the new owner must re-register the
facility using Form 3537.
What does the
registration number mean?
It
means that the owner of the facility has complied with this rule by
registering with FDA.
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