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§179.21 用于食品、包装食品检验和控制食品加工的辐照源

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放大字体  缩小字体 2011-12-23 07:17:40  来源:GPO  浏览次数:2550
核心提示:在符合(a)(b)所列条件下,辐照源可用于食品、包装食品检验和控制食品加工。其中(a)规定了辐照源需要满足的条件(b)规定了为确保安全使用辐照源,应做到:辐照源的标签应恰当准确的阐明辐照源的性质,标签和标签说明上详细说明如何安装使用辐照源。
发布单位
FDA
FDA
发布文号 21 CFR PART 179
发布日期 2004-12-21 生效日期 暂无
有效性状态 废止日期 暂无
备注 在符合(a)(b)所列条件下,辐照源可用于食品、包装食品检验和控制食品加工。其中(a)规定了辐照源需要满足的条件(b)规定了为确保安全使用辐照源,应做到:辐照源的标签应恰当准确的阐明辐照源的性质,标签和标签说明上详细说明如何安装使用辐照源。

  §179.21 Sources of radiation used for inspection of food, for inspection of packaged food, and for controlling food processing.
     

         Sources of radiation for the purposes of inspection of foods, for inspection of packaged food, and for controlling food processing may be safely used under the following conditions:

  (a) The radiation source is one of the following:

  (1) X-ray tubes producing X-radiation from operation of the tube source at a voltage of 500 kilovolt peak or lower.

  (2) Sealed units producing radiations at energy levels of not more than 2.2 million electron volts from one of the following isotopes: Americium-241, cesium-137, cobalt-60, iodine-125, krypton-85, radium-226, and strontium-90.

  (3) Sealed units producing neutron radiation from the isotope Californium-252 (CAS Reg. No. 13981-17-4) to measure moisture in food.

  (4) Machine sources producing X-radiation at energies no greater than 10 million electron volts (MeV).

  (5) Monoenergetic neutron sources producing neutrons at energies not less than 1 MeV but no greater than 14 MeV.

  (b) To assure safe use of these radiation sources:

  (1) The label of the sources shall bear, in addition to the other information required by the Act:

  (i) Appropriate and accurate information identifying the source of radiation.

  (ii) The maximum energy of radiation emitted by X-ray tube sources.

  (iii) The maximum energy of X-radiation emitted by machine source.

  (iv) The minimum and maximum energy of radiation emitted by neutron source.

  (2) The label or accompanying labeling shall bear:

  (i) Adequate directions for installation and use.

  (ii) A statement that no food shall be exposed to radiation sources listed in paragraph (a) (1) and (2) of this section so as to receive an absorbed dose in excess of 10 grays.

  (iii) A statement that no food shall be exposed to a radiation source listed in paragraph (a)(3) of this section so as to receive an absorbed dose in excess of 2 milligrays.

  (iv) A statement that no food shall be exposed to a radiation source listed in paragraph (a)(4) of this section so as to receive a dose in excess of 0.5 gray (Gy).

  (v) A statement that no food shall be exposed to a radiation source listed in paragraph (a)(5) of this section so as to receive a dose in excess of 0.01 gray (Gy).

  Code of Federal Regulations

  [42 FR 14635, Mar. 15, 1977, as amended at 48 FR 46022, Oct. 11, 1983; 61 FR 14246, Apr. 1, 1996; 64 FR 69191, Dec. 10, 1999; 66 FR 18539, Apr. 10, 2001; 69 FR 76404, Dec. 21, 2004]

  

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