Food Law- Oregon state

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202405
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Food Law- Oregon state
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2013-02-22 11:04:26
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OSU Food Law Exam
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OSU, Food Law Exam 2
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  1. what is the statutory definition of food (3)?
    • 1. articles used for food or drink for man or other animals
    • 2. Chewing gum
    • 3. articles used for components of any such article
  2. Imported food items must meet the same "adulteration" standards as domestically produced foods.
    True
  3. Explain how HACCP systems fit into the regulatory scheme used by the FDA to insure our food supply is safe.
    Hazard Analysis and Critical Control Point is systematic approach to food safety that is a preventative program meant to identify problems before they occur. Used by FDA in fish/fish related products and fruits/veggie juice industry
  4. would you expect a new flavorant (chemical that imparts flavor) to be approved for use in foods via the GRAS notification process?
    For a new flavorant no, there is not a large amount (or any) scientific data that is known or widely known about this new chemical.
  5. With respect to the 1997 FDA Modernization Act, what are "food contact substances" and how are they regulated.
    A notification is sent to the FDA detailing the additives intended use and safety of its use, if no response within 120 days then food contact additive can be used, at any time with new scientific data the food contact additive can be deemed unsafe for use.
  6. New synthetic sweeteners (sugar substitues) are typically approved via the GRAS notification process?
    True
  7. THe FDA may set "action levels" for a certain class of poisonous or deleterious substance. Explain
    THe action levels are guidelines set by FDA where they are set as more of a warning to producers to not go over those levels, action will be taken (probably) should a company be consistently over those levels but they are not legally binding to be under those action levels
  8. Some ingredients currently used as "GRAS substance" are not specified as such in FDA regulations. How can this be?
    They were approved to be in use before 1958 before the food additive amendment to the FDCA
  9. Pathogenic microorganisms may be considered as poisonous and/or deleterious substance for purpose of application of FDCA standards
    True (Blue ribbon smoked fish)
  10. Explain what "tolerances" are and how they come about.
    Tolerance come from unavoidable poisonous/deleterious substances through formal rule making and are legally binding.
  11. The EPA sets "tolerances" for what type of food contaminant?
    Pesticides
  12. Explain the legal diff btwn the outcome of the "affirmation process" and the "notification process" as applied to GRAS substances.
    • -Affirmation process is the resources intensive exercise of possibly having a new GRAS regulation made for that particular substance
    • -Notification process is the voluntary program that allows the informing of the FDA of a self determination of GRAS status rather than to petition for an affirmation.
  13. what are the two bases upon which GRAS status may be affirmed?
    • -Scientific procedures
    • -Experience based on common use in food prior to Jan 1, 1958(rarely used now)
  14. Based on your knowledge of the 1938 FDCA, draw lines connecting the most appropriate matches.
    "tolerance"- added constituents whose occurrence was unavoidable by GMP

    "ordinarily injurious" -added constituents that were neither necessary nor unavoidable

    "may render injurious" - constituents that were not added.
  15. "adulteration" is the central concept underlying FDA's regulation of the safety of food products.
    TRUE
  16. Economic Adulteration is covered in section 402 (b) of the FDCA. Give three cases under which a food may be deemed adulterated under these provisions
    • 1. Any valuable constituent has been in whole or in party omitted or abstracted
    • 2. Any substance has been substituted wholly or in part
    • 3. Damage or inferiority has been concealed in any manner
    • 4. any substance has been added/mixed packed therewith so as to increase its bulk or wight, or reduce quality or strength or make it appear better or greater value than it is.
  17. what is the major practical problem with strictly enforcing the "filthy, putrid, or decomposed" provision of the adulteration section of FDAC?
    All food has some sort of "filth" in it, just depends on how close you look
  18. define "de minimus filth"
    a small amount, doesnt matter.
  19. based on one provision of the FDCA, the FDA can rule a product "adulterated" without actually showing that the product is "contaminated or rendered injurious to health"
    Prepared, Packaged, or handled under insanitary conditions
  20. Name one segment of the food industry for which HACCP systems are mandated by either FDA or the USDA
    • meat/fish
    • vegetables/fruits
  21. Name two major food-borne microbial pathogens
    Salmonella, Listeria, E coli
  22. explain the role of "critical control points" in HACCP
    points in production that are high risk for contamination or possible safety issues
  23. According to the US Code (FDCA), substances seeking acceptance as food additives are presumed to be unsafe unless the additive has been subject to a pre-market approval by the FDA
    TRUE
  24. Explain the differences between a direct and indirect additive
    • direct- was intentionally put there
    • indirect- something added that was not intended
  25. what type of information is included in FDA's risk assessment guidelines ( the "red book") and how do these guidelines relate to the additive approval process?
    Approved methods for toxicological testing, these are the methods to use to show that your proposed product is safe (for now, not absolute)
  26. "food contact substances", as defined by the FDA Modernization Act, can be approved for use by a formal "notification" process.
    FDA informed by manufacturer of intent to use particular substances in interstate commerce, this is to seek approval w/out going through the length food additive petition process. Must ID as a food contact substance, intended use and explain determination that it is in fact safe to use, with relevant data to support. Presented 120 days prior to intended use data, this is how much time FDA has to show that it is unsafe before it is used, not permanent, can be revisited and shown to be unsafe.
  27. Are indirect additives subjet to the same statues and regulations as direct additives?
    NO, direct additives if an adulterant has a zero tolerance, where indirect may have a tolerance level, or an action level.
  28. What is the gov's general objective in requiring food processors to implement a HACCP system, what is the general strategy?
    it is a preventative system that IDs potential problems BEFORE they happen.
  29. Give two standards (conditions) under which a food may be deemed "adulterated" for reasons of safety under the FDCA.
    It has a directly added poisonous/deleterious substance, an indirectly added substance is at a level that is considered "ordinarily injurious"
  30. what is the primary objective of the food additives pre-market approval process of the FDA?
    To allow for an avoidable poisonous/deleterious substance to be approved as an additive at a level that would not cause harm.
  31. what is the statutory definition of "safe" for purpose of food additive approval?
    For the purpose of food additives approval means tat there is a reasonable certainty in the minds of competent scientist that a substance is not harmful under its intended conditions of use
  32. All food additives in use today have gone through the formal FDA pre-mareket approval process except those that have been deemed to have GRAS status.
    TRUE
  33. What is the general intent of the Delaney Clause of the FDCA?
    to eschew completely carcinogens in food
  34. what are "defect action levels", how do they apply, and why are they necessary?
    apply to filthy/putrid/decomposed substances, they are guidelines that are not likely taken alone to result in an enforcement action.
  35. with reference to the regulation of "food additives", explain the two major limitations of the 1938 FDCA which were rectified by promulgation of the 1958 Food Additives Amendment
    • 1. pre-market approval
    • 2. technology in food- avoidable poisonous/deleterious substances
  36. The US's first general, comprehensive, federal food law was enact in what year?
    1906
  37. According to the federal Food, Drug, and Cosmetic Act, foods containing avoidable poisonous or deleterious stubstances are adulterated
    TRUE
  38. what is the adulteration standard for food s with naturally occurring (not added) poisonous and deleterious substances?
    Ordinarily injurious
  39. the 1938 FDCA gives the FDA authority to establish "tolerance levels" for what class of compound?
    Poisonous and deleterious substances that cannot be avoided by GMP
  40. Why is it more common for the FDA to establish "action levels" for those compounds for which is had the authority to establish "tolerance levels"?
    Action levels leave flexibility for the fDA where they can go in and change it later, whereas with a regulation they have to go through the formal process and it if comes up in court they dont have any wiggle room around it. it takes a long time to change
  41. what are the legal implications of "tolerance levels" versus "action levels'
    • Tolerance- dont go above, it has been determined as a regulation
    • Action- guideline, does not necessitate action from the FDA, more of a danger zone.
  42. A provision of the FDCA allows the gov. to rule a product "adulterated without actually showing that the product is "contaminated or rendered injurious to health". Explain
    Prepared packed or handled under insanitary conditions. MAY have been contaminated (find rodent droppings, or hair, something like that)
  43. what is the common name used for the FDA guidance document that explains approved methods of toxicological testing for purposes of food additive approval?
    Red Book
  44. what disease condition is specifically addressed by the Delaney clause of the FDCA?
    Cancer
  45. Explain why the Delaney clause is often viewed as "outdated" and "inflexible" with reference to food additive approval
    Disallows ANY carcinogen in food, with ever advancing science comes the ability to detect compounds at even smaller concentrations (ppm,ppb, ppt)
  46. "color additives" are presumed to be unsafe and, thus, their inclusion in a food renders that food adulterated, unless the color additives have been subject to pre-market approval by the FDA
    TRUE
  47. IN contrast to food additives, there are not exclusions from pre-market approval for GRAS or prior sanctioned coloring compounds
    True?
  48. what does acronym GRASS mean?
    Generally Recognized As Safe
  49. Give one example of a GRAS substance
    salt, vinegar
  50. Explain the concept of GRAS self-determinatio and note whether or not such determinations are codified in the Code of Federal Regulations
    these self-determinations are not codified in the CFR because they have not gone through the formal rule-making process, this is done to free up resources from the lengthy approval process.
  51. why is it advantageous for a food component supplier, who will be selling those compoents within the food industry for further food formulation, to go through the FDA's GRAS Notification Program?
    • 1. Liability
    • 2. Makes you look more credible by "big players"
  52. In the FDCA "pesticides residues" are considered equivalent to "food additives"- having the sam regulations, exceptions, etc.
    FALSE- they are defined to not be food additives so they can avoid the Delaney LCuase
  53. Explain how the EPA and the FDA share responsibility for the regulation of pesticides in foods
    • Tolerances are set by the EPA
    • Enforcement done by FDA
  54. The Food Drug and Cosmetic Act of 1938, as amended, is the primary statute overseeing current food law
    TRUE
  55. what adulteration standard applied to avoidable, added, poisonous and deleterious substances
    May Render Injurious
  56. what adulteration standard applied to UNavoidable, added, poisonous and deleterious substances
    Ordinarily injurious
  57. which of the following are legally binding limits that are established through formal rule making for unavoidable added poisonous and deleterious substances in foods? a) Tolerances, b)Action levels, c) Affirmation of notification statement.
    Tolerances
  58. Why is the "unfit for food" statutory standard for adulteration rarely used by federal agencies as a basis for enforcement action? ( ie why would they prefer to use an alternative standard even if those cases where they feel the product is "unfit for food"
    How do you should that is it unfit for food? Too loose of a standard, varies too widely between the population as to who would say "that" is unfit for food.
  59. According to FDA representatives, what is considered the basis of the most challenging aspect of assuring food safety? (pesticides, microbial food-borne illness, filth in food, synthetic food additives, etc)
    Microbial food-borne illness (CDC tables)
  60. GMP regulations require which of the following
    a/ safe and sanitary production systems
    b/ mandatory, specific, procedures for achieving expected outcomes
    c/ both a and b
    d/ there are no formal federal GMP regulations
    A. Safe and sanitary production systems
  61. with regard to HACCP systems: A. Provide an example of a "critical control point" in a food processing operation of your choice and B. Provide an example of a "critical limit" that would apply to the critical control point you specified in part "a"
    Flow diversion valve on a milk pasteurizer
  62. For regulatory purposes, which of the following are not held to the adulteration standards established for "food additives"? a. color additives, b. pesticides cheimcals and c. GRAS substances
    GRAS substances
  63. "food additives' are presumed to be unsafe and thus, their inclusion in a food renders that food adulterated, unless the additives has been subject to pre-maket approval by the FDA
    TRUE
  64. Explain the FDA's rationale for wanting a de minimis exception to the Delaney Clause
    Our precision and ability to detect compounds at smaller and smaller concentrations brings concern that too many food items will eventually be considered unsafe by the Delaney Clause.
  65. Which of the following food components can legally be used in foods following a successful "notification process"? a; Food Contact Sunsatnces, b; GRAS substances c; Color Additives, d; Direct Food additives
    Food contact substances and GRAS substances
  66. Explain why the following compounds are unlikely to, or likely to, receive GRAS status, A. a new synthetic, flavor compound, B. A novel sweetener
    • A. unlikely because new and does not have data, or general knowlege that it is safe
    • B. Unlikely as well, same reasons
  67. Provide an example of how a compound that imparts color to food may not be regulated as a "color additive"
    Paprika, The secretary can deem something to not be a color additive from its use
  68. For the regulatory purposes, what is the difference between a "pesticide chemical" and a "pesticide residue"?
    • CHeimcal: any substance or mixture intended for preventing destroying, repelling a pest
    • Residue: a residue (or the chemical itself) or any added substance that is primarily the result of metabolism or other degradation of a pesticide chemical .
  69. Cases American Beauty Brand Oysters, why did the court apply the "ordinarily injurious" standard of adulteration to the deleterious substance?
    ordinarily injurious refers to "not added" or natural

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