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US The Bioterrorism Act of 2002 - How to comply. Must for indian food and marine product exporters

  • The Bioterrorism Act of 2002
    • U.S. FDA Facility Registration
    • U.S. FDA Prior Notice
  • Food Canning Establishment (FCE) Number

  • Compliance Policy Guide

The Bioterrorism Act of 2002

Q: When did the Bioterrorism Act become law?
A: President Bush signed the Bioterrorism Act, as enacted by the United States Congress, into law on June 12, 2002.

Q: What is the Bioterrorism Act of 2002?
A: According to the U.S. FDA, the events of September 11, 2001, highlighted the need to enhance the security of the U.S. food supply. Congress responded by passing the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 ("the Bioterrorism Act"). The Bioterrorism Act includes a provision which requires the Secretary of Health and Human Services to develop regulations mandating domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with the U.S. FDA. 

Q: What is the purpose of the Bioterrorism Act of 2002?
A: According to the U.S. FDA, in the event of an outbreak of food-borne illness, such information will help the U.S. FDA and other authorities determine the source and cause of the event. In addition, the registration information will enable the U.S. FDA to notify quickly the facilities that might be impacted by the outbreak.

Q: What are the main components of the law?
A: There are four major components of the law: Section 303 focuses on administrative detention; Section 305 focuses on food facility registration; Section 306 focuses on recordkeeping; and section 307 focuses on prior notice.

How the Bioterrorism Act of 2002 will affect your company

Q: Who must register with the U.S. FDA?
A: All U.S.-based and non-U.S.-based facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States must register with FDA by December 12, 2003.

Q: What happens if I missed the deadline?
A: If your business existed before the December 12, 2003, deadline, and you simply missed the registration deadline, you should register right away. Failure to register is a violation of U.S. law and you may be subject to civil or criminal penalties.

Q: My company is a new. I have missed the December 12, 2003 registration dealine. Do I still need to register even though I missed the deadline?
A: Yes. Failure to register is a violation of U.S. law and you may be subject to civil and criminal penalties.

Q: What is a "facility" and how can I calculate how many my company has?
A: The U.S. FDA defines a "facility" as any establishment, structure, or structures
under one management at one general physical location.

Q: If I am a U.S.-based company and only export product outside of the U.S. and never actually sell it on the U.S. market, do I need to register with the FDA?
A: Technically no. However, it may still be wise to obtain a registration number for your facilities.

Q: I am a non-U.S.-based company. Do I need a FDA registration agent?
A: Yes. According to the Bioterrorism Act, as a non-U.S.-based company you are required to name a U.S. agent.

Q: What is the registration deadline?
A: Product detentions for non-compliant companies started December 12, 2003.

Q: I am a U.S.-based company that packs, produces, manufactures, processes, or holds food and/or beverage products. What happens if I don't register?
A: Two consequences may occur if a facility covered under these regulations fails to register. Failure of either domestic or foreign facilities to register by December 12, 2003 is considered a prohibited act and the United States can bring a civil action in Federal court to enjoin persons who commit a prohibited act and can bring a criminal action in Federal court to prosecute persons who commit a prohibited act. Further, the U.S. FDA can seek debarment of any person who has been convicted of a felony relating to importation of food into the United States.

Q: What happens if my non-U.S.-based suppliers don't register?
A: For foreign facilities that fail to register and attempt to export food to the United States, the Bioterrorism Act requires the food be held at the port of entry unless the U.S. FDA directs its removal to a secure facility. In addition, failure to register by December 12, 2003 register is considered a prohibited act and the United States can bring a civil action in Federal court to enjoin persons who commit a prohibited act and can bring a criminal action in Federal court to prosecute persons who commit a prohibited act. Further, the U.S. FDA can seek debarment of any person who has been convicted of a felony relating to importation of food into the United States.

Q: Am I responsible for registering my non-U.S.-based suppliers?
A: No, you are not. However, their failure to obtain a registration number may result in the detention of products you have purchased from them. Thus, it is wise to be sure that your trading partners are in full compliance with the law.

Q: If my U.S.-based company is only an office and never actually manufactures, processes, packs, or holds food for human or animal consumption that we sell, do we still need to register?
A: More than likely not. However, it may still be wise to obtain a registration number for your facility.

Q: If my non-U.S.-based company is only an office and never actually packs, produces, manufactures, processes, or holds any of the food or beverages we sell to the United States, do we still need to register?
A: More than likely not. However, the company that supplied you with the products you are selling more than likely is obligated to register. Additionally, it may still be wise to obtain a registration number for your facility as well.

Q: If my non-U.S.-based company is only an office and never actually packs, produces, manufactures, processes, or holds any of the food or beverages we sell to the United States, will my suppliers need to register?
A: The company that supplied you with the products you are selling more than likely is obligated to register.

Q: How long will it take to receive my registration number(s)?
A: Completing our simplified registration forms should take less than 10 minutes. Once you submit the forms to us by fax or mail, we should be able to obtain your U.S. FDA Registration Number in 24 hours or less.

Q: I never pack, produce, manufacture, process, or hold any of my own products. My inventory is kept at a public cold or dry storage facility. Will this public storage facility need to register?
A: Facilities located outside the United States that take possession, custody or control of finished foods for holding, packing, and/or storage prior to export to the United States, are required to register.

Q: I produce pet or animal feed. Do I need to register?
A: Yes. Any food produced for animal consumption is covered under this law.

U.S. FDA Prior Notice

Q: Is Prior Notice and Bioterrorism Act registration the same thing?
A: No. Registration is a one-time process required for a physical location where a food or beverage for human or animal consumption is "manufactured, processed, packed, or stored". Prior Notice is a different process whereby the US FDA is notified of an arriving shipment before it actually arrives in the U.S. Prior Notice must be filed for each and every shipment. 

Q: Who must file Prior Notice?
A: Either the overseas exporter or the U.S. importer may file Prior Notice. In the case of FOB shipments, the U.S. importer may be the most logical party to file Prior Notice. In the case of CIF shipments, the overseas exporter may be the most logical party to file Prior Notice.

Q: When must Prior Notice be filed?
A: Prior Notice may be filed no earlier than 5 days before the arrival of the shipment in the U.S., and must be filed no less than 2 hours if arriving by land, 4 hours if arriving by air, or 8 hours if arriving by sea.

Q: When and how is the Prior Notice requirement being enforced?
A: The Prior Notice requirement came into effect on December 12, 2003. Failure to file Prior Notice is a violation of the law, and could result in a shipment being detained or refused entry into the U.S.

Q: If I am arriving in the U.S. by air and carring food or beverages with me, do I need to file Prior Notice?
A: No. If the products are for personal consumption you do not need to file Prior Notice.

Q: If I am sending sending food or beerage samples for a trade show in the U.S., do I need to file Prior Notice?
A: Yes. Prior Notice is required for samples.

Interational Mail and Prior Notice

Q: Are individuals who are not in the food or beverage industry and are simply sending food by mail required to file Prior Notice?
A: Yes. If you are mailing food or beverages by international mail or international express mail (such as FedEx, DHL, or UPS), you are required to file Prior Notice.

Q: Are there any exemptions to the rules pertaining to Prior Notice and international mail?
A: Yes. If the food or beverages you wish to mail are homemade, then you do not need to file Prior Notice.

Food Canning Establishment (FCE) Number

Q: What does "FCE" stand for?
A: Food Canning Establishment.

Q: Who must register for an FCE number?
A: Commercial processors of low-acid and acidified foods produced in or exported to the United States must obtain an FCE number issued by the U.S. Food and Drug Administration.

Q: What is a "low-acid" food?
A: A "low-acid" food is any food other than alcoholic beverages with a finished equilibrium pH greater than 4.6 and a water activity (aw) greater than (0.85). Tomatoes and tomato products having a finished equilibrium pH less than 4.7 are not classified as low-acid foods.

Q: What is an "acidified" food?
A: An "acidified food" is a low acid food to which acid or acid foods are added and which have a water activity (aw) greater than 0.85 and a finished equilibrium pH of 4.6 or below.

Q: Do I have to register if I use packaging other than cans, e.g., jars?
A: Yes, if the food is a low-acid or acidified food and no other exception applies. The word "canning" as used in the acronym "FCE" includes all aseptic packaging methods.

Q: If my company has more than one processing facility, must each of them be registered separately?
A: Yes. Each processing facility must have a separate FCE number.

Q: If my company moves its processing facility, may I continue to use the FCE number from the prior location?
A: No. A new FCE registration is required when your facility changes.

Q: What are the consequences of failing to obtain an FCE number?
A: Low-acid and acidified foods produced by facilities without an FCE registration may be refused entry to the U.S., and civil and criminal penalties may apply.

Q: What is a SID filing?
A: In addition to registering their facilities and obtaining an FCE number, processors must file forms describing in detail the manufacturing process used for each product. Each process filing is called a SID filing and is designated an identifying SID number.

Q: Can a processor submit SID filings with its initial FCE registration?
A: Yes. Can a processor submit SID filings without having or applying for an FCE registration? No. An FCE number is required for all SID filings except those made together with an initial FCE registration.

Q: What are the consequences for failing to obtain SID numbers?
A: Low-acid and acidified foods produced by facilities without proper SID filings may be refused entry to the U.S., and civil and criminal penalties may apply.
 

Compliance Policy Guide

Prior Notice of Imported Food Under the
Public Health Security and Bioterrorism Preparedness
and Response Act of 2002

This guidance document represents the Food and Drug Administration's (FDA) and Customs and Border Protection's (CBP) current thinking on this topic.  It does not create or confer any rights for or on any person and does not operate to bind FDA, CBP, or the public.  An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.

Sec. 110.310:  Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002

INTRODUCTION:

The purpose of this document is to provide guidance on FDA's and CBP's strategy for enforcing and otherwise achieving compliance with the requirements of the interim final rule for submitting prior notice for food imported or offered for import into the United States (68 Fed. Reg. 58974 (Oct. 10, 2003) (to be codified at 21 CFR 1.276 – 1.285)).

FDA's guidance documents, including this Compliance Policy Guide, do not establish legally enforceable responsibilities.  Instead, guidance documents describe the agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word should in agency guidance documents means that something is suggested or recommended, but not required.

BACKGROUND:

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act), section 307, added section 801(m) to the Federal Food, Drug, and Cosmetic Act (the Act) to require that FDA receive prior notice for food imported or offered for import into the United States.  Section 801(m) also provides that if an article of food arrives at the port of arrival with inadequate prior notice (e.g., no prior notice, inaccurate prior notice, or untimely prior notice), the food is subject to refusal of admission under section 801(m)(1) of the Act and may not be delivered to the importer, owner, or consignee.  If an article of food is refused under section 801(m)(1) of the Act, unless CBP concurrence is obtained for export and the article is immediately exported from the port of arrival under CBP supervision, it must be held within the port of entry for the article unless directed by CBP or FDA.

The Bioterrorism Act, section 305, also amended Chapter IV of the Act by adding section 415 to require domestic and foreign facilities that manufacture, process, pack, or hold food for consumption in the United States to register with FDA, and amended Chapter VIII of the Act by adding section 801(l) to require any food for human and animal consumption from an unregistered foreign facility that is imported or offered for import to be held at the port of entry until the foreign facility has been registered.

On October 10, 2003, FDA and CBP issued interim final regulations establishing the requirements for registration and requiring that FDA receive prior notice of the importation of food beginning on December 12, 2003 (68 FR 58994 and 68 FR 58974).   For the purposes of prior notice, "food" has the meaning given in section 201(f) of the Act, and is defined as (1) articles of food or drink for man or other animals, (2) chewing gum, and (3) articles used as components of any such article, except that it does not include food contact substances or pesticides.  The requirements for prior notice do not apply to:

  1. (1) Food for an individual's personal use when it is carried by or otherwise accompanies the individual when arriving in the United States;
  2. (2) Food that was made by an individual in his/her personal residence and sent by that individual as a personal gift (i.e. for non-business reasons) to an individual in the United States;
  3. (3) Food that is imported then exported without leaving the port of arrival until export;
  4. (4) Meat food products that at the time of importation are subject to the exclusive jurisdiction of the U.S. Department of Agriculture (USDA) under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.);
  5. (5) Poultry products that at the time of importation are subject to the exclusive jurisdiction of USDA under the Poultry Products Inspection Act (21 U.S.C. 451 et seq.); or
  6. (6) Egg products that at the time of importation are subject to the exclusive jurisdiction of USDA under the Egg Products Inspection Act (21 U.S.C. 1031 et seq.).

Information required to be submitted in a prior notice includes, with certain exceptions, the registration numbers assigned to the foreign manufacturer's and shipper's facilities that are associated with the article of food.  FDA's monitoring of compliance by foreign facilities with the requirement to register under section 415 of the Act will be accomplished primarily through the prior notice review process.   If an article of food is from a foreign manufacturer that is not registered as required and is imported or offered for import, then the food is subject to refusal under section 801(m)(1) of the Act for failure to provide adequate prior notice.  Likewise, the failure to provide the correct registration number of the relevant foreign manufacturer, if registration is required, renders the identity of that facility incomplete for purposes of prior notice.  In addition, if an article of food is imported or offered for import from any foreign facility that is not registered as required, then the food is subject to being held under 801(l) of the Act.

In the preamble to the interim final rule, FDA stated that it planned to provide guidance to its staff  regarding the agency's enforcement policies.  FDA also stated its intent to provide a transition period, during which it would emphasize education on the prior notice requirements to help industry achieve compliance with the regulation.  Accordingly, this Compliance Policy Guide establishes policies regarding the enforcement of the prior notice requirements, including the requirement to provide a required registration number.

Policy:

The requirements for submitting prior notice to FDA are effective beginning December 12, 2003.  However, as described below, during the first eight months following this effective date, FDA and CBP plan to focus their resources on education to achieve compliance with the prior notice requirements.  While educational efforts will be made in response to specific violations, FDA and CBP also intend to continue their broad, pro-active educational initiatives during the initial eight-month period, including the following:

  1. FDA and CBP will distribute information flyers at the ports.
  2. FDA and CBP plan to:
    1. Gather data to track compliance with the prior notice requirements and to determine how best to use their resources to educate industry and the public in order to achieve full compliance.
    2. Provide industry and the public with summary information about the level of compliance with the prior notice requirements, including data on the types of errors in submitted prior notices.
    3. Provide the summary information on FDA's website at www.fda.gov.
    4. Utilize the data and summary information to assist the industry and the public in improving the submission of prior notice.

FDA may consider the failure to provide adequate prior notice as a factor in determining whether and where to examine an article of food.  However, during this eight-month period and after, if FDA decides not to refuse an article of food under 21 CFR 1.283 or 1.285, this decision has no bearing on whether the article of food is admissible or will be granted admission under other provisions of the Act or other U.S. laws.  Thus, for food that is imported or offered for import, FDA will continue its normal review, investigative, and enforcement activities for food safety and security concerns to determine whether the food is subject to refusal under section 801(a) of the Act.  In addition, if FDA decides not to refuse an article of food under 21 CFR 1.283 or 1.285, this decision does not affect FDA's ability to initiate other types of actions -- such as seizures, injunctions, prosecutions, or debarments under sections 302, 303, 304, and 306 of the Act -- that may be necessary.  Likewise, it does not affect CBP's ability to initiate other types of actions that may be necessary.

REGULATORY ACTION GUIDANCE:

FDA's Prior Notice Review Center, in conjunction with CBP headquarters, should use the tables below to make decisions about whether to refuse a shipment of food pursuant to 21 CFR 1.283 or 1.285 for violations under sections 801(m) and 415 of the Act.

The following definitions and descriptions apply to the tables.

Types of Violations

  1. Inadequate Prior Notice
    1. No Prior Notice - The article of food arrives at the port of arrival and no prior notice has been submitted and confirmed by FDA for review.
    2. Inaccurate Prior Notice - Prior notice has been submitted and confirmed by FDA for review, but upon review of the notice or examination of the article of food, the prior notice is determined to be inaccurate.
    3. Untimely Prior Notice - Prior notice has been submitted and confirmed by FDA for review, but the full time that applies under 21 CFR 1.279 for prior notice has not elapsed when the article arrives, unless FDA has already reviewed the prior notice, determined its response to the prior notice, and advised CBP of that response.
  2. Unregistered Facility - The article of food is imported or offered for import from a foreign facility that is not registered as required.
  3. No PN Confirmation
    1. When a copy of the Prior Notice (PN) Confirmation is required for food carried by or otherwise accompanying an individual, but cannot be provided by the individual.
    2. When the PN Confirmation Number is not affixed to an article of food that arrives by international mail.

Categories of Violations

Category 1 Violations -  Available credible evidence or information, including information in the prior notice, if any, indicates that the article presents a threat of serious adverse health consequences or death to humans or animals.

Category 2 Violations - The violation:

  1. (a) Reflects a history of repeated conduct of a similar nature by a person who has been notified of such violations; or
  2. (b) Appears to be intentional or flagrant.

Category 3 Violations - All violations other than those that fall within Category 1 or 2.

Actions in Response to Violations

Education/Communication - To the extent possible:

  1. (a) Distribute information flyers at the ports to carriers and others associated with the shipment of food.
  2. (b) Provide, to the extent practicable, notice of the violation and of the prior notice and registration requirements to the person(s) who transmits and/or files the prior notice.
  3. (c) When an article of food that is carried by or otherwise accompanying an individual is not for personal use and has inadequate prior notice or the individual cannot provide FDA or CBP with a copy of the prior notice (PN) confirmation, provide the individual with an information sheet on prior notice.
  4. (d) When an article of food arrives by international mail with inadequate prior notice or the PN confirmation number is not affixed, provide an information sheet on prior notice and forward the package to the addressee.

Assessment of CBP Civil Monetary Penalties - CBP, in consultation with FDA, may assess civil monetary penalties for violation of  19 U.S.C. 1595a(b) against any party who aids or abets the importation of any merchandise contrary to law.

Refusal - FDA, in consultation with CBP, may refuse admission of an article of food under section 801(m)(1) of the Act or place it under hold under section 801(l) of the Act for violations under sections 801(m) and 415 of the Act.  If an article of food is refused or placed under hold under these provisions, unless CBP concurrence is obtained for export and the article is immediately exported from the port of arrival under CBP supervision, it must be held within the port of entry for the article unless directed by CBP or FDA.  21 CFR 1.283(a) and 1.285(a), (b).  For food that is carried by or otherwise accompanying an individual, and is refused, and if, before leaving the port, the individual does not arrange to have the food held at the port or exported, the article of food shall be destroyed.  21 CFR 1.283(b) and 1.285(h).  For food that arrives by international mail and is refused, if there is a return address, the parcel will be returned to sender stamped "No Prior Notice – FDA Refused."  If there is no return address, or if FDA determines that the article of food in the parcel appears to present a hazard, FDA may dispose of or destroy the parcel.  21 CFR 1.283(e) and 1.285(k).

Table 1 - Implementing 21 CFR 1.283(a) and 1.285(a), (b). Shipments of food, other than food carried by or otherwise accompanying an individual or food arriving by international mail. Table 1 describes actions FDA and CBP staff typically should consider taking when an article of food is imported or offered for import into the United States with inadequate prior notice.  It does not apply to food arriving by international mail or food carried by or otherwise accompanying an individual.

Table 2 - Implementing 21 CFR 1.283(b) and 1.285(h). Food carried by or otherwise accompanying an individual.  Table 2 describes actions FDA and CBP staff typically should consider taking when an article of food that is carried by or otherwise accompanying an individual is not for personal use and has inadequate prior notice or the individual cannot provide FDA or CBP with a copy of the PN confirmation.

Table 3 - Implementing 21 CFR 1.283(e) and 1.285(k). Food arriving by international mail.  Table 3 describes actions FDA and CBP staff typically should consider taking when an article of food arrives by international mail with inadequate prior notice or the PN confirmation number is not affixed as required.

The phrase "the action FDA and CBP staff typically should consider taking" used in the tables means that FDA and CBP staff, pursuant to their agency's policies and procedures, may take these actions or may take different or additional actions if they believe particular circumstances warrant them.

Table 1:    Implementing 21 CFR 1.283(a) and 1.285(a), (b).  Shipments of food, other than food carried by or otherwise accompanying an individual or food arriving by international mail.*
If the violation occurs: and if the violation is due to: then for violations that fall within Category 3, the action FDA and CBP staff typically should consider taking is: then for violations that fall within Category 2, the action FDA and CBP staff typically should consider taking is: then for violations that fall within Category 1, the action FDA and CBP staff typically should consider taking is:
December 12, 2003
to
March 12, 2004		 (1) No prior notice Education/ communication. Analysis of data for compliance action. Education/ communication. Analysis of data for compliance action Refusal and possible CBP civil monetary penalties.
(2) Inaccurate prior notice, untimely prior notice, or an unregistered facility Education/ communication. Analysis of data for compliance action. Education/ communication. Analysis of data for compliance action. Refusal and possible CBP civil monetary penalties.
March 13, 2004
to
May 12, 2004		 (1) No prior notice Education/ communication. Analysis of data for compliance action. Assessment of CBP civil monetary penalties. Refusal and possible CBP civil monetary penalties.
(2) Inaccurate prior notice, untimely prior notice, or an unregistered facility Education/ communication. Analysis of data for compliance action. Education/ communication. Analysis of data for compliance action. Refusal and possible CBP civil monetary penalties.
May 13, 2004
to
August 12, 2004		 (1) No prior notice Refusal. Refusal and/or assess CBP civil monetary penalties. Refusal and possible CBP civil monetary penalties.
(2) Inaccurate prior notice, untimely prior notice, or an unregistered facility Education/ communication. Analysis of data for compliance action. Assess CBP civil monetary penalties. Refusal and possible CBP civil monetary penalties.
After
August 12, 2004		 (1) No prior notice Refusal and/or assess CBP Civil Monetary Penalties. Refusal and/or assess CBP civil monetary penalties. Refusal and possible CBP civil monetary penalties.
(2) Inaccurate prior notice, untimely prior notice, or an unregistered facility Refusal and/or Assess CBP civil monetary penalties. Refusal and/or Assess CBP civil monetary penalties. Refusal and possible CBP civil monetary penalties.

* Definitions and descriptions of the types of violations, categories of violations, and actions in response to violations are given above

Table 2:    Implementing 21 CFR 1.283(b) and 1.285(h).  Food carried by or otherwise accompanying an individual.*
If the violation occurs: and if the violation is due to: then for violations that fall within Category 3, the action FDA and CBP staff typically should consider taking is: then for violations that fall within Category 2, the action FDA and CBP staff typically should consider taking is: then for violations that fall within Category 1, the action FDA and CBP staff typically should consider taking is:
December 12, 2003
to
August 12, 2004		 (1) Inadequate prior notice or an unregistered facility Education/ communication. Education/ communication. Refusal.
(2) No PN confirmation Education/ communication. Education/ communication. Refusal.
After
August 12, 2004		 (1) Inadequate prior notice or an unregistered facility Education/ communication (minor or inadvertent problems) or refusal. Refusal. Refusal.
(2) No PN confirmation Education/ communication (minor or inadvertent problems) or refusal. Refusal. Refusal.

* Definitions and descriptions of the types of violations, categories of violations, and actions in response to violations are given above.

Table 3:    Implementing 21 CFR 1.283(e) and 1.285(k).  Food arriving by international mail.*
If the violation is on or after: and if the violation is due to: then for violations that fall within Category 3, the action FDA and CBP staff typically should consider taking is: then for violations that fall within Category 2, the action FDA and CBP staff typically should consider taking is: then for violations that fall within Category 1, the action FDA and CBP staff typically should consider taking is:
December 12, 2003
to
August 12, 2004		 (1) Inadequate prior notice or an unregistered facility Education/ communication. Education/ communication. Refusal.
(2) No PN confirmation Education/ communication. Education/ communication. Refusal.
After
August 12, 2004		 (1) Inadequate prior notice or an unregistered facility Education/ communication (minor or inadvertent problems) or refusal. Refusal. Refusal.
(2) No PN confirmation Education/ communication (minor or inadvertent problems) or refusal. Refusal. Refusal.

* Definitions and descriptions of the types of violations, categories of violations, and actions in response to violations are given above.

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