Food Safety Modernization Act

Transcription

1 Allianz Global Corporate & Specialty SE Food Safety Modernization Act FDA Regulations Inland & Ocean Cargo Transportation Law Council Albuquerque, New Mexico May 2, 2016

2 Edward Ward Carmack November 5, 1858 November 9, 1908 Thanks to the recently released FDA Regulations on April 6, 2016 Senator Carmack may finally pass on?

3 21 CFR Part 1 Subpart O Who is Subject to this Subpart? (a) Except for non-covered businesses as defined in and as provided for in paragraph (b) of this section, the requirements of this subpart apply to shippers, receivers, loaders, and carriers engaged in transportation operations whether or not the food is being offered for or enters interstate commerce.

4 21 CFR Part 1 Subpart O Who is Subject to this Subpart? (b) The requirements of this subpart do not apply to shippers, receivers, loaders, or carriers when they are engaged in transportation operations: (1) Of food that is transshipped through the United States to another country; or (2) Of food that is imported for future export, in accordance with section 801(d)(3) of the Federal Food, Drug, and Cosmetic Act, and that is neither consumed nor distributed in the United States; or (3) Of food when it is located in food facilities as defined in of this chapter, that are regulated exclusively, throughout the entire facility, by the U.S. Department of Agriculture under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21 U.S.C et seq.).

5 21 CFR Part 1 Subpart O What Requirements Apply to Transportation Operations? (a) General Requirements. (1) An entity subject to this subpart (shipper, loader, carrier, or receiver) may reassign, in a written agreement, its responsibilities under this subpart to another party subject to this subpart.

6 21 CFR Part 1 Subpart O What Requirements Apply to Transportation Operations? (b) Requirements applicable to shippers engaged in transportation operations (c) Requirements applicable to loaders engaged in transportation operations. (d) Requirements applicable to receivers engaged in transportation operations (e) Requirements applicable to carriers engaged in transportation operations

7 21 CFR Part 1 Subpart O What Requirements Apply to Transportation Operations? General Requirements. (6) If a shipper, loader, receiver, or carrier becomes aware of an indication of a possible material failure of temperature control or other conditions that may render the food unsafe during transportation, the food shall not be sold or otherwise distributed, and these persons must take appropriate action including, as necessary, communication with other parties to ensure that the food is not sold or otherwise distributed unless a determination is made by a qualified individual that the temperature deviation or other condition did not render the food unsafe.

8 21 CFR Part 1 Subpart O What Requirements Apply to Transportation Operations? (d) Requirements applicable to receivers engaged in transportation operations. Upon receipt of food that requires temperature control for safety under the conditions of shipment, the receiver must take steps to adequately assess that the food was not subjected to significant temperature abuse, such as determining the food s temperature, the ambient temperature of the vehicle and its temperature setting, and conducting a sensory inspection, e.g., for off-odors.

9 CARGO UNDERWRITING Covered by Regs Requirements (responsibilities) / Contract Risk Transfer Transportation Operations Claims Covered / Not Covered

10 Inland Cargo Coverage Perils Covered We cover risks of direct physical loss unless the loss is limited or cause by a peril that is excluded.

11 Inland Cargo Coverage Civil Authority We do not pay for loss caused by any civil authority, including seizure, confiscation, destruction or quarantine of property.

12 Inland Cargo Coverage Loss of Use We do not pay for loss caused by or resulting from loss of use, delay or loss of market.

13 Inland Cargo Coverage Pollutants We do not pay for loss caused by or resulting from release, discharge, seepage, migration, dispersal or escape of pollutants : 1) unless the release, discharge, seepage, migration, dispersal or escape is caused by a Specified Cause of Loss or 2) except as specifically provided under the Supplemental Coverage Pollutant Clean Up and Removal.

14 Inland Cargo Coverage Spoilage We do not pay for loss to Perishable Stock caused by Spoilage.

15 Inland Cargo Coverage Perishable Stock means property preserved and maintained under controlled conditions and susceptible to loss or damage if the controlled conditions change.

16 Inland Cargo Coverage Spoilage means any detrimental change in physical state of perishable stock. Detrimental change includes, but is not limited to, thawing of frozen foods, warming of refrigerated goods, or solidification of liquid material.

17 Inland Cargo Coverage Supplemental Coverage Cold Storage Coverage - We cover direct physical loss resulting from spoilage to perishable stock of others that you store at your warehouse.

18 Inland Cargo Coverage If Your Responsibility for Covered Property is Reduced If the amount of your responsibility is reduced we will not pay more for loss to Covered Property than the reduced amount of your responsibility, plus the cost of labor, materials or services furnished or arranged by you. The reduced amount of your responsibility will be based on an amount: 1) set by Law; or 2) lawfully set by you in a bill of lading, contract of carriage or shipping receipt that is issued by you or that is issued on your behalf.

19 Ocean Cargo Coverage 16. CONDITIONS OF COVERAGE: 16.1 All goods and/or merchandise and/or property, except those listed in Sub-Clause , are insured: Against all risks of physical loss or damage from any external cause, except those risks as may be excluded by the F.C. & S. warranty, S.R. & C.C. warranty and/or other warranties or exclusions specified in this policy unless covered elsewhere herein, irrespective of percentage.

20 Ocean Cargo Coverage 16. CONDITIONS OF COVERAGE: 16.2 The goods and/or merchandise and/or property listed in Sub-Clause are insured: Against all risks of physical loss or damage from any external cause, except those risks as may be excluded by the F.C. & S. warranty, S.R. & C.C. warranty, or other warranties or exclusions specified in this policy, unless covered elsewhere herein, but warranted free of particular average unless the vessel or craft be stranded, sunk, burnt or in collision (these risks are referred to as the FPA Perils ).

21 Ocean Cargo Coverage 23.2 DELIBERATE DAMAGE - SERVICES: This insurance also covers, notwithstanding the F.C. & S. warranty specified in this policy, and subject to all other insuring terms, conditions and warranties set forth elsewhere in this policy, physical loss of and damage to the shipment arising out of the performance of inspection duties by customs service agents or other duly constituted governmental agencies.

22 Ocean Cargo Coverage 28. CONTROL OF DAMAGED GOODS AND/OR MERCHANDISE AND/OR PROPERTY: 28.1 Notwithstanding anything to the contrary contained elsewhere in this policy, it is understood and agreed that in case of damage, or if The Insured reasonably suspects damage may exist, to goods and/or merchandise and/or property insured under this policy, The Insured is to retain full and absolute discretion and control over the disposition of all such goods and/or merchandise and/or property. It is understood that The Insured shall be the sole judge as to whether disposal or sale of such goods and/or merchandise and/or property is detrimental to its interest.

23 Ocean Cargo Coverage 28. CONTROL OF DAMAGED GOODS AND/OR MERCHANDISE AND/OR PROPERTY: 28.2 Any goods and/or merchandise and/or property which The Insured deems unfit for sale or which it is unable to sell or dispose of under its agreement with any trade association or other entity, shall be treated as a constructive total loss, and The Insured shall dispose of the goods and/or merchandise and/or property to its best advantage with This Insurer being entitled to its share of the net proceeds resulting from such disposition, or the goods and/or merchandise and/or property shall be destroyed after notification to This Insurer and any expenses incurred in connection with such destruction shall be borne by This Insurer. This Insurer shall be given the opportunity to have a representative in attendance during such destruction.

24 Ocean Cargo Coverage 39. REFUSED OR RETURNED SHIPMENT: This insurance covers, subject to the applicable insuring conditions set forth elsewhere in this policy, all shipments which may be refused and are to be returned by the consignee or others while awaiting shipment or reshipment and until received by The Insured or otherwise disposed of.

25 Ocean Cargo Coverage 44. SUE AND LABOR: 44.1 In the case of any imminent or actual loss or misfortune, it shall be lawful and necessary to and for The Insured, its factors, servants and assigns, to sue, labor and travel for, in and about the defense, safeguard and recovery of the goods and/or merchandise and/or property insured hereunder, or any part thereof, without prejudice to this insurance The acts of The Insured or This Insurer in recovering, saving and preserving the insured goods and/or merchandise and/or property in case of disaster, shall not be considered a waiver or an acceptance of an abandonment.

26 Ocean Cargo Coverage 45. DELAY: This insurance is warranted free from, and shall not cover, loss of market or loss, damage or expense arising from delay, regardless of whether such delay is caused by a risk insured against or otherwise, unless such risks are expressly assumed elsewhere in this policy.

27 Public Comment #42 Response: SALVAGE The owner of the product can pursue other lawful options, such as reconditioning the product or diverting the product to nonfood uses. If, however, the food has not been offered for sale in the United States and otherwise meets the requirements of section 801(e)(1) of the FD&C Act, it can be shipped abroad and would not be subject to the adulterated food provisions of the FD&C Act and therefore would not be subject to this rule.

28 Public Comment #43 Response: We recognize the burdens and uncertainties that may arise when a load is rejected. However, the basis on which a load may be rejected, and the disposition of and costs associated with the disposal of rejected loads of food, are beyond the scope of this rule. We do not agree that we should explore the development of rules to govern rejections and/or cargo insurance claims, or rejected product disposal issues, because they often involve purely economic considerations about food shipments, which do not fall within our jurisdiction. Also, issues of liability are similarly subject to Federal laws that we do not have the authority to administer. DISPOSITION

29 Public Comment #46 Response: BROKEN SEALS!!! A broken cargo seal or any evidence of food cargo tampering would not necessarily create a per se presumption of adulteration. However, we advise persons engaged in transportation operations that, if such situations should arise, they should carefully evaluate the facts and circumstances of each incident, on a case-by-case basis, to determine whether the safety of the food cargo may have been compromised.

30 IS Senator Carmack Finally Dead For Food and Beverage Covered by the FSMA FDA Regulations? OR Do you believe in Ghosts?...

31 Sam Rizzitelli Transportation Practice Leader agcs.allianz.com