ICL 2.pptx

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INTERNATIONAL CUSTOMS LAW –

U.S. Code of Regulations(Agriculture)

Copyright © 2004 by The McGraw-Hill Companies, Inc. All rights reserved.

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INTERNATIONAL CUSTOMS LAW – U.S. Code of Regulations

Agriculture Animals, Plants and By Products Commerce and Trade Customs Duties Foods & DrugsWaters Post Service Transportation

Copyright © 2004 by The McGraw-Hill Companies, Inc. All rights reserved.

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U.S. Code of Regulations (Agriculture)

Purpose & Scope The Provision of Agricultural Bioterrorism Protection Act of 2002 set the requirements for possession, use, and transfer of selected agents and toxins.

PPQ Select Agents and Toxins - (Functions) Except as provided in par. (d) and (e), the

Administrator has determined that biological agents and toxins have been determined to have the potential severe threat to plant health or to plant products.

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PPQ Select Agents and Toxins - (Exclusions) An individual or entity must submit a written

request and supporting scientific info. Written decision granting or denying the request will be issued.

If an excluded toxic is subjected to manipulation, the resulting select agent or toxin will be subjected to additional requirements and Documentation.

Any agent or toxin seized by Federal Law enforcement agency will be excluded from the required documentation during the period between seizure and transfer or destrutcion of such agent or toxin.

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PPQ Select Agents and Toxins - (Exclusions) An individual or entity must submit a written

request and supporting scientific info. Written decision granting or denying the request will be issued.

If an excluded toxic is subjected to manipulation, the resulting select agent or toxin will be subjected to additional requirements and Documentation.

Any agent or toxin seized by Federal Law enforcement agency will be excluded from the required documentation during the period between seizure and transfer or destrutcion of such agent or toxin..

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PPQ Select Agents and Toxins - (Exemptions)

Diagnostic laboratories and other entities that possess, use, or transfer a select agent or toxin that is contained in a specimen presented for diagnosis.

The Administrator may grant a specific exemption upon showing of good cause and upon his/her determimination that such exemption is consistent with protecting plant health or plant products.

Request for reconsideration must state all the facts and reasons upon which the individual or entity relies to show that the exemption was wrongfully denied.

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Registration and Related Security Risk Assessments

Unless exempted an individual or entity shall not possess, use or transfer any select agents or toxin without a certificate of registration issued by the Administrator.

As a condition of registration, each entity must designate an individual to be its responsible official.

In the event that an individual applies for and is granted a certificate or registration, the individual will be considered the responsible official.

As a condition of registration it must be approved by the Administrator or the HHS Secretary based on a security risk assessment by the Attorney General.

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An entity will be considered to be an institution of higher education if it is an institution of higher education.

To obtain a security risk assessment, an individual or entity must submit the information necessary to conduct a security risk assessment to the Attorney General.

To apply for a certificate of registration for only PPQ select agents or toxins, or for PPQ and VS select agents/toxins, an individual/entity must submit the information requested in the application registration form (APHIS/CDC Form 1).

Prior to issuance of a certificate or registration, responsible official must promptly provide notification of any changes to the application for registration by submitting the relevant page(s) of the registration application.

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Issuance of certificate of registration may be continent upon inspection of additional information

A certificate will be valid for one physical location (a room, a building, or a group of buildings) where official/personal will be able to perform the duty required.

Certificate of registration may be amended to reflect changes in circumstances (e.g. replacement of responsible official or personnel, changes in ownership, control of the entity, changes in the activities involving any select agents or toxins, or the addition/removal of select agents or toxins).

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Prior to any change, the responsible official must apply for amendment to certificate of registration by submitting the relevant (page(s) of the registration form.

Responsible official will be notified in writing if the application to amend has been approved.

No changes may be made without such approval.

An entity must immediately notify APHIS or CDC if it loses the services of its responsible official

Certificate of registration will be terminated upon written request of the entity (if the entity no longer possesses or uses any select agents or toxins and no longer wishes to be registered

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Denial, Revocation , or Suspension of Registration

If the individual/entity, the responsible official/individual who owns or controls the entity is within any of the categories described in 18 U.S.C. 175b

If the individual/entity, the responsible official/individual, who owns or control the entity is reasonably suspected by any Federal law enforcement or intelligence (committed a crime, involved in terrorism, agent of a foreign power)

Individual/entity does not meet the requirement.

Action is necessary to protect plant health or plant products.

On revocation/suspension of a certificate of registration – individual/entity: (should stop all the use of each select agent or toxin, safeguard & secure each select agent or toxin, comply with all disposition instructions issued by the Administrator, denial can be appealed).

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Responsible Official

An individual or entity required to register under this part must designate an individual to be the responsible official and he must: - Approved by the Administrator or HHS Secretary following a

security risk assessment by the Attorney General; - Be familiar with the requirements; - Have the authority and responsibility to act on behalf of the entity; - Ensure compliance with the requirements; - Have a physical presence at the registered entity - Ensure that annual inspection are conducted of each laboratory where

select agents or toxins are stored or used

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An entity may designate or more individuals to serve as an

alternate responsible official who acts for the responsible

official in his/her absence

The responsible official must report the identification and final

disposition of any select agent or toxin contained in a

specimen for diagnosis or verification -

- The identification of the select agent6 or toxin must be immediately reported by telephone, facsimile, or e-mail

- Less stringent reporting may be required during agricultural

emergencies or outbreaks, or in endemic areas.

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Restricting Access to Select Agents and Toxins; Security Risks Assessments

An individual or entity required to register under this part may not provide an individual access to a select agent or toxin, and an individual may not access a select agent or toxin unless the individual is approved by the Administrator.

An individual will be deemed to have access at any point in time if the individual has possession of a sle4ct agent or toxin.

Each individual with access to select agents or toxins must have the appropriate agent or toxin must have appropriate education, training and/or experience to handle or use such agents or toxins..

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Restricting Access to Select Agents and Toxins; Security Risks Assessments

To apply for access approval, each individual must submit the information

necessary to conduct a security risk assessment to the Attorney

General;

A persona with approval to have access to select agents or toxins may

request through his or her responsible official;

An individual’s security risk assessment may be expedited upon written

request by the responsible official and a showing of good cause;

An individual’s access approval may be denied – - An individual is within any of the categories, described in 18

U.S. 175B.- The individual is reasonably suspected by Federal law

enforcement or intelligence agency of committing a crime

.

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Restricting Access to Select Agents and Toxins; Security Risks Assessments - (effective Until Apr 3,

2013)

An individual’s access approval may be denied –

- It is determined that such action is necessary to protect plant health

or plant products;

- An individual may appeal the Administrator’s decision to deny,

limit or revoke access approval;

- Access approval is valid for a maximum of 3 years;

- The responsible official must immediately notify APHIS or CDC

when individual access to select agent or toxins is terminated by the

entity and the reasons thereof

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Security - (effective April 3, 2013) An individual or entity required to register must develop and implement a written security plan.

The security plan must be designed according to a site-specific risk assessment and provide graded protection and must:

- Describe procedures for physical security, inventory control and

info systems control;- Control provisions for the control access- Contain provision for routine cleaning, maintenance and

repairs;- Establish procedures for removing unauthorized or

suspicious persons;- Describe procedures for addressing loss or compromise of

keys, passwords, combinations etc;-

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Security - (effective April 3, 2013)- Contain procedures for reporting unauthorized or

suspicious persons or activities, loss or theft.- Contain procedures for ensuring that all individuals with

access approval understand comply with the security procedures;

- Describe procedures for how the Responsible Official will be

informed of suspicious activity that may be criminal in nature and

related to the entity, its personnel, or its select agents or toxins

- Ensure that all external connections to systems which security are

isolated or have controls that permit only authorized users;

- Ensures that authorized and authenticated users are only granted

access to select agent and toxins related info, files, equipment;

- Ensures that controls are in place that are designed to prevent

malicious code;- Establish procedures that provide backup security

measures in the event that access control systems are rendered

inoperable;

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Security - (effective April 3, 2013)- Contain provisions and policies for shipping, receiving

and storage of select agents and toxins, including documented

procedures and entity will properly secure containers on site and have a

written contingency plan for unexpected shipments.

An individual or entity must adhere to the following security requirements or implement measures to achieve an equivalent or greater level of security

- Allow access only to individual with access approval - Allow individual not approved for access by Administrator

or HHS Secretary to conduct routine cleaning, maintenance and

repair only when escorted by an approved individual;

- Provide for control of select agents and toxins of freezers, refrigerators, cabinets and other containers to be secured

against unauthorized access;

.

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Security - (effective April 3, 2013) An individual or entity must adhere to the following security requirements or implement measures to achieve an equivalent or greater level of security

- Inspect all suspicious packages before they are brought into or

removed from used or stored;

- Separate areas where select agents and toxins are stored or used

from the public areas of the building;

- Entities must conduct complete inventory audits of all affect select

agents and toxins in long-term storage

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Biocontainment

An individual or entity are required to register and must develop and implement a written biocontainment plan that is commensurable with the risk of the select agent or toxin, given its intended use. Biocontainment must contain sufficient info and documentation to describe the procedures;

Biocontainment procedures must be sufficient to contain the select agent or toxin (e.g. physical structure & features for the entity, operational & procedural safeguards) and must have containment facilities and safeguards, Practical Guide to Containment, greenhouse Research, etc., Plant must be reviewed annually and revised when necessary, Drills must be conducted at least annually and the plant must reviewed and reviewed when necessary after any drill or exercise and after any incident.

.

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Restricted Experiments

An individual or entity may not conduct or possess products resulting from experiments unless approved by and conducted in accordance with the conditions prescribed by the Administrator:

-Experiments that involve deliberate transfer or selection for drug or chemical resistance trait to select agents that are not known to acquire the trait naturally

-Experiments with deliberate formation of synthetic or recombinant nucleic acids for biosynthesis of select toxins;

-Administrator may revoke approval or suspend certificate of registration if the individual or entity fails to comply with the requirements.

- To apply for approval to conduct any of the experiments, individual or entity must submit a written request and supporting info to Administrator;

-A written decision granting or denying the request will be issued.

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Training

An individual or entity are required to register and must

provide info and training on biocontainement, biosafety,

security (including security awareness) and incident

response

Training and refresher training must be provided annually for

individuals with access by HHS Secretary orAdministrator

Responsible official must ensure a record of the training

provided to each individual. Record must contain name

of the individual, date of training description of training

and means used to verify that employee understood the

training.

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Transfers

A select agent or toxin may only be transferred to an individual or entity registered to possess, use or transfer that agent or toxin must be authorized by APHIS or CDC, if:

- If the sender meets all the requirements

- Meets the exemption requirements

- Transfer from outside of the U.S. meets all import requirements

- Recipient has certificate of registration

- On case-to-case basis the Administrator may authorize or not authorized under the conditions prescribed by the Administrator.

- APHIS/CDC Form 2 must be submitted.

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Records

An individual or entity must maintain complete records relating to the activities such as:

- Accurate current inventory for each select agent, held in a long-term storage such as freezer;

-The name and characteristics (e.g. strain, designation, numbers etc.)

-Quantity acquired from anther individual or entity (e.g. containers, vials, tubes etc)

-Where stored (building, room and freezers);

-When moved from storage and by whom and when returned to storage and by whom;

- Select agent used and purpose of use

- Records created (n0tification of theft, loss or release);

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Notification of Theft, Loss or Release

An individual or entity must immediately notify APHIS or CDC upon discovery of the theft or loss of a select agent or toxin even if the select agent or toxin is subsequently recovered or the responsible parties are identified;

1) Theft or loss of a select agent or toxin must be reported by telephone, facsimile, or email and must provide –

-Name of select agent or toxin and any identifying information (e.g. strain or other characterization information);

-Estimated time during which the theft or loss occurred;

-Location (building, room) from which the theft or loss occurred; and

-List of Federal, State or local law enforcement agencies to which the individual

or entity reported, or intents to report, the theft or loss.

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Notification of Theft, Loss or Release (cont’d)

2) A Completed APHIS/CDC Form 3 must be submitted within 7 calendar days

- An individual or entity must notify APHIS or CDC immediately upon discovery of a

release outside of the primary barriers of the biocontainment area.

- Name of select agent or toxin and any identifying information (e.g. strain or other

characterization information);

- Estimated quantity released;

- Time and duration of the quantity released;

- Location (building, room) from which the theft or loss occurred;

- Number of individual exposed at the entity;

- Hazards posed by the release;

- A completed APHIS/CDC Form 3 must be submitted within 7 calendars.

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Administrative Review

An individual or entity may appeal a denial, revocation, or suspension of registration;

- Appeal must be in writing, state the factual basis for the appeal;

- Submitted to the Administrator within 30 calendars days of the decision

An individual or entity may appeal a denial, revocation, limitation, or revocation of access approval; - Appeal must be in writing, state the factual basis for the appeal;

- Submitted to the Administrator within 180 calendars days of the decision

- The Administrator’s decision constitutes final agency action

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Abbreviations & Definitions of TermsAdministrator – The Administrator, Animal and Plant Health

Inspector Service, or any person authorized to act for the Administrator Animal and Plant Health Inspection Service (APHIS) and Plant Health Inspection Service of the U.S. Dept. of Agriculture.

APHIS - Animal and Plant Health Inspection Service and Plant Health inspection Service

Attorney General – The Attorney General of U.S.A. or any person authorized to act for the Attorney General

Biological Agent – Any microorganism but not limited to bacteria viruses, fungi or protozoa) or infectious substance, or any naturally occurring, bioengineered, or synthesized component of any microorganism or infections substance capable of causing, death, disease, or biological malfunctions, deterioration of food and deleterious alteration of the environment.

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Abbreviations & Definitions of TermsDiagnosis – Analysis of specimens for the purpose of identifying

or confirming the presence or characteristics of agents or toxin provided that such analysis is directly related to protecting the public health or safety, animal health or animal products, or plant health or plant products.

Entity – Any government agency, academic institution, corporation, company, partnership or other legal entity

Integrity – Guarding against improper information modification or destruction and includes ensuring information authenticity

Confidentiality – preserving authorized restrictions on access and disclosure – including means for protecting personal privacy and proprietary information

Availability – ensuring timely and reliable access to and use of information.

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Abbreviations & Definitions of TermsInterstate – From one State into or through any other State, or

within the District of Columbia, Guam, The Virgin Island of the U.S or any other territory or possession of the U.S.A.

Permit – A written authorization by the Administrator to import or move interstate select agents or toxins, under conditions prescribed by the Administrator

PPC – Plant Protection and Quarantine Programs of the Animal and Plant Health Inspection Service

Recombinant Nucleic Acids – Molecules that are constructed by joining nucleic acid molecules and that can replicate in a living cell.

Responsible Official – Individual designated by any entity with the authority and control to ensure compliance with the regulations in this part.

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Abbreviations & Definitions of TermsSpecimen – Samples of material from humans, animals, plants or

the environment or isolates or cultures from such samples, for diagnosis, verification or proficiency testing

State – Any of the several States of the U.S.A., the Commonwealth of Puerto Rico, District of Columbia, Guam, the Virgin Islands of the U.S. or any the territory or possessions of the U.S.

Toxin – The Toxic material or product of plants, animals, microorganisms (including but not limited to bacteria, viruses, fungi or protozoa) or infections substances, or a recombinant or synthesized molecule, whatever their origin and method of production.

Verification – The demonstration of obtaining established performances (e.g. accuracy, precision, and the analytical sensitivity and specifications) for any procedure used for diagnosis.

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Abbreviations & Definitions of TermsCDC – Centers for Disease Control and Prevention

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ASSIGNMENT

List and Search on – “Animals & Animal Products” U.S. Customs Laws

1) Definitions

2) Purpose & Scope

3) Exemptions

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ASSIGNMENTEnumerate at least 10 (each group) goods/articles thatenter U.S.A . & the Philippines (a) taxable, (b) highly Taxable and, © Free of Duties- include the percentage

of Duties levied.

ITEMS

PHILIPPINES U.S.A.

TAXABLE HIGHLY TAXABLE FREE OF DUTIES TAXABLE HIGHLY

TAXABLE FREE OF DUTIES

1 Textile 31%

2 Wheat 81%

3 TV for Demo 0%

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ICL 2.pptx