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SANDLER, TRAVIS & ROSENBERG, P.A. An International Trade and Business Practice

TPM - Cool Cargoes

Supporting a Safe & Secure Global

Food Supply Chain

Presented by:

Lenny Feldman, Esq.

Sandler, Travis & Rosenberg, P.A.

March 3, 2014

© 2009 Sandler, Travis & Rosenberg, P.A. All rights reserved.

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Disclaimer

2


Relevant Agencies


Food & Drug Administration


Import Review Process

5


Food Drug & Cosmetic Act FDA

Section 801 of the FD&CA states:

―If it …appears from the examination of such samples or otherwise

(1)such article has been manufactured, processed, or packed under insanitary conditions… or

(2)such article is forbidden or restricted in sale in the country in which it was produced … or

(3)such article is adulterated, misbranded, or in violation of section 505 (New Drugs)

then such article shall be refused admission…”

6


Food Drug & Cosmetic Act FDA

―or otherwise‖ – allows FDA to make admissibility

decisions using:

Examinations

Facility Inspection

Laboratory examination

Historical Data

Lack of required processes and/or approvals

Other sources, e.g., a disease outbreak involving

an FDA regulated product

Labeling

Reports from other Governmental and State

Agencies

7


Detention Authority

• BTA: grants administrative detention authority

over food items if credible evidence or

information indicates the food presents a threat

of serious adverse health consequences or

death to animals or humans.

• FSMA: broadens authority, allowing for

administrative detention based on ‗reason to

believe‘ that the food item has been misbranded

or adulterated and violates a legal standard for

the product.

8


FDA Review - Food

• Facility registration numbers under BioTerrorism Act

• Low acid (LACF) and Acidified (ACD) Canned Foods

• Food Canning Establishment Number (FCE)

• Approved Scheduled Process Submission ID (SID)

• Process for adequate acidification

• Prior notice

• Food for use, storage, or distribution in U.S.

• Food transshipped through U.S. to another country

• Food imported for future export

• Food for use in FTZ

• Time frames prior to arrival – Truck 2 hours; Rail 4 hours; Air 4

hours; Water 8 hours.

• Compliant, sufficient labeling

9


FDA Review – Food (2)

• Applicable import alerts

• Violative history of commodities,

manufacturers/shippers, growers, geographic area,

countries of origin, importers, combination of issues

• Detention Without Physical Exam based on

evidence from field offices or foreign inspections;

foreign govt, state or agency

• Removal from DWPE by submitting petition,

reviewed by FDA with evidence usually of five non-

violative shipments (may require laboratory analysis)

• Assurance cause of violation corrected

10


Key Highlights of New FSMA Requirements Include

Substantially Enhanced FDA Records Inspection

Authority

FDA Can Unilaterally Suspend a Food

Facility‘s Registration and Require the

Manufacturer to Seek Reinstatement.

FDA Required to Impose Hazard Analysis

and Critical Control Points Evaluation Requirements on

Covered Manufacturers.

FDA Required to Mandate Use of Specific

Good Agricultural Practices in Growing

and Handling of Produce.

FDA Required to Improve Tracking and

Tracing of Food Distribution to Facilitate

Investigation and Resolution of Foodborne

Illness Outbreaks.

FDA Now Has Explicit Legal Authority to Mandate a Recall.

FDA‘s Evidence Burden to Embargo Food For Safety Reasons Until the Agency Can Bring an Action in Court is Substantially Eased.

Significantly Expands FDA‘s Authority to Regulate Safety of Food Domestically Produced or Imported

Food Safety Modernization Act

11


• Effective January 4, 2011

• Most significant change to U.S. food

supply regulations since 1938

• Creates a comprehensive risk-based

preventive approach to food safety

• Over 50 guidances and/or regulations to

be published over a 3-year period

• Increased inspections over the next 5-7

years of foreign facilities

Additional Background

12


Implemented: Food Facility Registration §102

13

BIOTERRORISM ACT (2002)

• Registration required for all foreign food facilities with FDA

• Designation of US Agent for every facility

• No penalty for not updating information

• Essentially a ―one-time‖ registration

FSMA §102

• Re-registration of ALL foreign & domestic food facilities on or

before January 31, 2013

• Re-registration every 2-years

• Consent to expanded records and facility inspection

• Expanded requirement for classification of food categories

• U.S. Agent liable for payment of facility reinspection fees to FDA


January 2013

• Hazard Analysis and Risk-Based Preventive Controls for Human

Food amending Current Good Manufacturing Practice, Jan. 4, 2013 (―Preventive Controls Rule‖ §103)

• Standards for Growing, Harvesting, Packing and Holding of Produce for Human Consumption, Jan. 4, 2013 (―Produce Safety Rule‖ § 105)

February 2013

• Final Rule on Administrative Detention of Food

July 2013

• Foreign Supplier Verification Program

• Third-Party Auditor Accreditation

December 2013

• Intentional Adulteration of Food

January 2014

• Sanitary Transportation of Food

Proposed Rules: Timeline/Overview

14


FDA Required to Mandate Food

Transportation Safety Standards.

•Requires Food Transporters to Use Sanitary Transportation Practices to Ensure Food Safety

•Applies to Shippers, Receivers, and Carriers Who Transport Food in U.S. by Motor or Rail

•Applies ex-U.S. also, e.g. Exporter Who Ships Food to the U.S. in International Freight Container By Sea or in Air Freight Container and Arranges for Transfer of Intact, Container Onto Motor Vehicle or Rail Carrier in the U.S.

•Such an ex-U.S. Exporter Is Considered a ―Shipper‖ Under Proposed

•Rule Because Exporter Effectively Initiates Shipment of Food, Even if Doing So From Abroad

FDA‘s Authority Over Foreign Food Imports

Greatly Expanded.

•Importers Required to Perform Supplier Verification Activities

•FDA Can Refuse Admission of Imported Food if Foreign Facility or Foreign Government Refuses to Permit Inspection

•FDA Now Has Authority to require certification, based on risk criteria, that imported food in compliance with U.S. food safety requirements

•FDA to Develop a Voluntary Qualified Importer Program That Permits Qualified Importers Who Take Certain Measures to Receive Expedited Review of Imported Shipments

Important Points for Supply Chain Partners

15


PROPOSED RULE ON SANITARY TRANSPORTATION OF FOOD

Establishes Numerous Requirements Covering Following Areas

• Vehicles and Transportation Equipment—Covers design and maintenance of

vehicles and transportation Equipment

• Transportation Operations—Covers measures, e.g. Adequate Temperature

Controls and Separation of Food and Non-Food Items to Prevent Contamination

• Information Exchange—Cover Procedures for Information Exchange Between

Shipper, Carrier, and Receiver About, e.g. Prior Cargoes, Cleaning of Transport

Equipment, Temperature Control. Example: Information About Possible Cross

Contamination Due to Prior Carriage of Liquid Products Containing Allergen and

Methods Use to Prevent Contamination of Product Now Being Shipped

• Training—Training of Carrier Personnel in Sanitary Transportation Practices and

Documentation of Training

• Records—Maintain Written Procedures and Records By Carriers and Shippers

Related to Transportation Equipment Cleaning, Prior Cargos, and Temperature

Control

• Waivers—FDA Can Waive Certain Requirements If It Makes Determination That

Waiver Will Not Result in Unsafe Food Transportation Practices

Proposed Sanitary Transport Rule (Jan. 2014)

16


FDA Proposed Rule on Foreign Supplier Verification

Proposed FSVP - §301

17

• Compliance Status Review

• Hazard Analysis

• Verification Activities

• Corrective Actions

• Periodic Reassessment of the FSVP

• Importer Identification

• Recordkeeping

FSVP includes the following:


FSVP – Key Definitions

18

• Who is the Importer?

– The person in the U.S. who purchased the food

– If the food has not been sold to a person in the U.S., the importer

is the U.S. consignee.

– If there is no owner or consignee, the importer is the U.S. agent

or representative of the foreign supplier.

• Who is the foreign supplier?

– The farm that raised the animal or harvested the imported food

or

– The last foreign establishment that manufactured or processed

the imported food in more than a minimal matter (examples of

minimally processed are adding a label, packing, or holding).


FSVP - Fundamentals

19

• Objective: Importers required to perform certain risk-based activities to

verify that food imported into the U.S. has been produced in a manner that

provides the same level of public health protection as that required of

domestic food producers

• Proposed regulations vary based on the following:

– On the type of food product (e.g. processed foods, produce, and dietary

supplements)

– The category of importer

– The nature of the hazard in the food, and

– Who is to control the hazard

• Requirements

– All importers must establish and follow an FSVP (unless exempted)

– Under proposed rule, an importer is required to develop, maintain, and

follow an FSVP for each food it imports.


• Options for control include:

– The Importer: must document (at least annually) that

it has established and is following procedures that

adequately control the hazard

– The Importer’s Customer: Importer must obtain

written assurance, at least annually, that its customer

has established and is following the procedures

identified in the written assurance to adequately

control the hazard

– The Foreign Supplier or Its Supplier: 2 Options

FSVP - Control of Hazards

20


FSVP - Control of Hazards

21

Option 1: if Foreign Supplier Controls the Hazard at its Establishment, AND:

(1) reasonable probability that hazard will result in serious hazards (SAHCODHA), requires:

– annual on-site audit of the foreign supplier by the importer or by a third-party

– Can rely on inspection results of FDA or an FDA-sanctioned food safety authority (e.g. New

Zealand)

(2) Non-serious hazards (non-SAHCODHA)

– conduct 1 or more of the verification activities listed below (in determining proper verification

activity, must consider risk presented by hazard/food and foreign supplier‘s compliance

status).

Option 2: For all hazards that the foreign supplier or its supplier will control, importers must

choose a verification procedure from among:

(a) onsite auditing,

(b) sampling and testing,

(c) review of supplier food safety records, or

(d) some other appropriate procedure.

Determining proper verification activities and frequency = evaluation of risk presented by hazard,

probability that exposure to the hazard will result in serious harm, and food/foreign supplier‘s

compliance status.


FSVP - What is Actually Sufficient?

22

• FDA‘s flexibility can create troubles

– Assessing whether a hazard could result in SAHCODHA is a subjective

standard, could present practical challenge under Option 1. On-site

auditing for such hazards may be difficult to perform

– Option 2 provides greater flexibility in obtaining supplier verification;

option 2 appears more favorable to importers for verification activities if

permitted:

• How to prepare/justify the rationale for your verification activity (on-

site auditing vs. sampling/testing vs. records review)

– What documents should you maintain?

– Specific food safety protocols in any given FSVP plan will depend on

several factors, including inherent risks associated with the food,

country of origin of the food, and manufacturers involved in the supply

chain


Covered facilities required to establish and implement a food safety system that includes a hazard analysis and risk-based preventive controls.

Requirements for:

• A written food safety plan;

• Hazard analysis;

• Preventive controls for hazards that are reasonably likely to occur;

• Monitoring;

• Corrective actions;

• Verification; and

• Associated records.

Proposed Preventive Controls Rule - §103

23


Objective: Science based minimum standards for safe production and harvesting of fruits and vegetables.

• Covers fruits and vegetables while they are in raw or natural (unprocessed) state.

Proposed rule does NOT apply to fruits and vegetables destined for commercial processing that will reduce microorganisms of public health concern.

Proposed rule is based on FDA‘s evaluation of science and risk-analysis. Focuses on specific risk areas

of risk, primarily:

• agricultural water quality;

• biological soil amendments of animal origin;

• worker health and hygiene;

• contamination from domesticated and wild animals in the growing area; and

• standards for equipment, tools and buildings.

• training Requirements

Proposed produce rule is intended

• to be flexible for different-sized farms,

• to complement conservation laws and rules,

• to not conflict with laws and rules for organic farming.

Proposed Produce Safety Rule - § 105

24


– FDA will have comprehensive oversight of a credible and reliable

program for third-party audits.

– Accreditation body must meet FDA standards and requirements

– FDA receives reports of third-party audits conducted for

certification purposes (regulatory audits)

– FDA has monitoring and oversight over system including

procedures that FDA will follow to remove an

auditor/accreditation body from the program for good cause

– Must maintain records, provide FDA access to records, monitor

its own performance, and protect against conflicts of interest

Proposed Third-Party Auditor Accreditation - §307

25


Requirements for Recognized Accreditation Bodies

26

Rule sets forth eligibility requirements for recognition as an accreditation body

Accreditation Body can be a foreign government/agency or private third-party

Must meet standards for legal authority, competency and capacity, impartiality/objectivity, quality assurance, and records procedures

• Asses third-party auditors for accreditation;

• Monitor performance of the third-party auditors it accredits and notify the FDA of any change in, or denial of, accreditation;

• Conduct self-assessments and correct any problems in its own performance;

• Submit reports and other notifications to the FDA;

• Protect against conflicts of interest; and

• Maintain and provide the FDA access to records

Requirements of accreditation bodies


Use of Accredited Third-Party Auditors

27

Third-party will be used for the following purposes:

1. Voluntary Qualified Importer Program (VQIP)

2. Condition of entry for certain foods.

3. As part of an importer‘s FSVP (optional)


U.S. Customs & Border Protection


CBP Process

29

ENFORCEMENT AND

COMPLIANCE PROCEDURES

Compliance Measurement

ISA

Regulatory Audit

Targeted Industries/Issues National/Port/Broker

Account Management

Investigations

Interventions

CEEs -

Transformation

C-TPAT

Focused

Assessment


• Origin and trade preference programs

• Classification and value - duties

• Bonded facilities & foreign trade zones

• Duty drawback

• Clear, accurate invoices and entry

information

• Genuine trademarks

Critical CBP Considerations


Transforming Cargo Clearance

31


Centers of Excellence &

Expertise

32

• Utilize account based methods

• Expand partnerships

• Comprehensive risk management

Facilitate legitimate trade

through risk segmentation

• Advance bi-directional education to raise industry knowledge

• Engage industry groups and key stakeholders

• Bring CBP‘s single industry expertise to virtual environment

Increase industry-based knowledge

within CBP

• Leverage industry to identify issues of mutual interest to provide CBP with targeting, enforcement, and/or intelligence information

• Coordinate enforcement efforts by industry to address unique risks

Enhance enforcement and address industry

risks


CEEs At a Glance

33


• Voluntary partnership to promote legitimate trade

and enhance border security

• Businesses implement established security criteria

• In exchange, CBP provides reduced inspections at

port of arrival and expedited processing at border

• C-TPAT members 3 to 8 times less likely, on

average, to receive inspections or exams

C-TPAT Certification – ―Fast Lane‖


Animal & Plant Health Inspection Service


Animal and Plant Health Inspection Service

• Objectives:

• Animals - monitor health of animals and regulate

import and export of animals, animal products

and biologicals.

• Plants - monitor the movement of risk material,

protect against the introduction of pests and

regulate the import and export of plants.

• Treatments are fruit and origin specific.

• Fruit is subject to PPQ compliance inspection upon

entry.

36


APHIS Perishables - Checklist

• Consider whether PPQ Form 587, Permit to Import

Plants or Plant Products is required. Valid for five

years.

• Obtain proof that fruit underwent necessary

treatment prior to entry.

• Consider whether PPQ Form 203, Plant Export

Certificate or other governmental certificate of

treatment is required to obtain release.

• Consider any Agricultural Marketing Service (AMS)

compliance inspection upon entry.

37


APHIS Perishables - Checklist

• Consider Fruits and Vegetables Import Requirements

(FAVIR). Quarantine 56 or Q56 regulations.

• Consider Country Summary – Approved imports

(provides plant part and ports of entry)

• Note Commodity Import Report (CIR) - Inspection

requirements

• Be familiar with Frequently Asked Questions –

Database, Treatment, Permits/E-Permits,

Phytosanitary Certificates

• Stay aware of Import Alerts

• Consider Fresh Fruits and Vegetables Import Manual

38


Cold Treatment

39

IN TRANSIT on shipboard

or

AFTER ARRIVAL in approved cold storage warehouses at Ports

North of 39⁰ latitude and East of 104⁰ longitude or at:

• Wilmington, NC

• Seattle, WA

• Seattle Tacoma International Airport

• Corpus Christi, TX

• Gulfport, MS

• Hartsfield International Airport

• Washington Dulles International Airport

• Chantilly, VA

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