Regulatory Updates

Distribution date: 14 October 1999

Products Covered: The Agreement covers several product categories, called "sectors". The sectors which are covered are: medicinal products good manufacturing practice inspection and batch certification (30, HS 2), machinery (84, HS 2), low voltage equipment (85, HS 2), telecommunications terminal equipment (8517, HS 4), electromagnetic compatibility (85, HS 2), medical devices (9018, HS 4), and pressure equipment.

Regulation Type: Article 10.7 (TBT)

Distribution date: 30 August 1999

Products Covered: This Agreement applies to products traded between Switzerland and Canada as well as to procedures which are subject to specified legislative, regulatory and administrative provisions pertaining to conformity assessment and technical regulations, as detailed in five sectoral annexes to the Agreement, in the areas of: Telecommunications terminal equipment (ch. 85.17), Electromagnetic compatibility (EMC) & Electrical Safety (ch. 85, except 85.17), Good Manufacturing Practices (ch. 30) and Medical Devices (ch. 90.18, 90.19, 91.20, 91.21, 19.22).

Regulation Type: Article 10.7 (TBT)

Distribution date: 29 July 1999

The Food and Drug Administration (FDA) is announcing the availability for comment of three draft guidance documents developed by the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products. Document 1 provides guidance recommendations for applications for marketing authorizations on the content and qualification of impurities in new veterinary medicinal products produced from chemically synthesized new active substances not previously registered in a member state. Document 2 is an annex to the parent guidance VICH GL3 entitled "Stability Testing of New Drug Substances and Products in the Veterinary Field". This draft guidance document is the annex and addresses of the recommendations for stability testing of veterinary medicinal Type A medicated articles (referred to as medicated premix drug products in the draft guidance) intended for submission for approval to the European Communities, Japan, and the United States. Document 3 is draft guidance for industry entitled "Impurities in New Veterinary Drug Substances" and is intended to assist in developing registration applications for approval of veterinary medicinal products submitted to the European Communities, Japan and the United States

Products Covered: Veterinary medicinal products

Regulation Type: Regular notification

Distribution date: 29 July 1999

The Food and Drug Administration (FDA) is proposing to amend its regulations to reclassify sheep as a minor species for all data collection purposes. This would allow sponsors of supplemental new animal drug applications (NADA's) to extrapolate human food safety data from a major species such as cattle to sheep. In particular, this will allow the extrapolation of the tolerances for residues of new animal drugs in cattle to sheep.

Products Covered: Animal drugs

Regulation Type: Regular notification

Distribution date: 14 July 1999

The Food and Drug Administration (FDA) has determined that certain new animal drugs, vital to animal health, should be approved for use in animal feed, but only if such medicated feeds are administered under a veterinarian's order and supervision. This limitation is important for a number of reasons. For example, control of the usage of certain antimicrobials is critical to reducing unnecessary use of such drugs in animals and to slowing or preventing the development of bacterial resistance to antimicrobial drugs. FDA is proposing to amend the animal drug regulations to implement the Veterinary Feed Directive (VFD) drugs section of the animal Drug Availability Act (ADAA). A VFD drug is intended for use in animal feeds, and such use of the VFD drug is permitted only under the professional supervision of a licensed veterinarian. The proposed regulation would establish the requirements relating to the distribution and use of VFD drugs and animal feeds containing VFD drugs.

Products Covered: Animal drugs

Regulation Type: Regular notification

Distribution date: 28 May 1999

The Food Safety and Inspection Service (FSIS) is amending the Federal meat inspection regulations to allow the use of soy protein concentrate, both singly and in combination with modified food starch or carrageenan, as a binder in cured pork products labelled "Ham with Natural Juices", "Ham Water Added", and "Ham and Water Product -- X% of Weight is Added Ingredients", and to increase the permitted use level of modified food starch as a binder in "Ham and Water Product -- X% of Weight is Added Ingredients" products. These binders will be used to reduce purging of the pumped brine solution from the products. FSIS is proceeding with this direct final rule in response to petitions submitted by Central Soya and the National Starch and Chemical Company and informal requests from several food manufacturers.

Products Covered: Ham

Regulation Type: Regular notification

Distribution date: 21 May 1999

The Food and Drug Administration (FDA) is proposing to amend its regulations pertaining to the registration of foreign establishments and the listing of human drugs, animal drugs (including animal feed bearing or containing an animal drug for non-investigational uses), biological products (will not affect veterinary biologics as they are regulated by USDA), and devices. The proposal would require foreign establishments whose products are imported or offered for import into the United States to register with FDA. The proposal would also require foreign establishments to identify a United States agent and would describe some of the agent's responsibilities. The Agency is proposing these changes to implement section 417 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) as it pertains to foreign establishment registration.

Products Covered: Animal drugs, human drugs, biological products, and devices

Regulation Type: Regular notification

Distribution date: 14 May 1998

The Food and Drug Administration (FDA) is amending its regulations to lift the stay of the effective date for the allowable levels in the bottled water quality standard for nine chemical contaminants, i.e., antimony, beryllium, cyanide, nickel, thallium, diquat, endothall, glyphosate, and 2,3,7,8-TCDD (dioxin), that was imposed in a final rule published on March 26, 1996. By lifting the stay of the effective date, bottled water manufacturers will be required to monitor source waters and finished bottled water products at least once a year for these nine chemical contaminants under the current good manufacturing practice (CGMP) regulations for bottled water. These bottled water products will also be subject to possible testing by FDA to these standards. FDA is required to issue monitoring requirements for the nine chemical contaminants under the Safe Drinking Water Act Amendments of 1996. FDA is using direct final rulemaking for this action because the agency expects that there will be no significant adverse comment on the rule. FDA is also publishing today a companion proposed rule under FDA's usual procedure for notice-and-comment rulemaking to provide a procedural frame work to finalize the rule in the event the agency receives significant adverse comments and withdraws this direct final rule. The companion proposed rule and direct final rule are substantively identical. If no timely significant adverse comment is received in response to the direct final rule, the agency will publish a confirmation notice no later than 6 August 1998 confirming the effective date of the direct final rule.

Products Covered: Bottled water

Regulation Type: Regular notification

Distribution date: 20 March 1998

The Food and Drug Administration (FDA) is issuing a tentative final rule to amend its regulations to affirm that egg white lysozyme enzyme preparation, when labelled by the common or usual name "egg white lysozyme" to identify its source, is generally recognized as safe (GRAS) for use in preventing late blowing of cheese caused by the bacterium Clostridum tyrobutyricum during cheese production. FDA has tentatively concluded that this use of the egg white lysozyme enzyme preparation is GRAS only when the ingredient statement for both bulk and packaged food that contains cheese manufactured using egg white lysozyme included the common or usual name "egg white lysozyme" to identify the source of the protein. Egg whites are known to be an allergenic food source, particularly in children. There is a literature report indicating that lysozyme may in fact have been an allergen for some individuals who became sensitive to egg whites. Although the reported in vitro study does not establish that ingestion of egg white lysozyme in cheese will actually cause a clinically significant allergic reaction in such sensitive individuals, FDA is not aware of any data or information that would refute the study's inference that egg white lysozyme may be allergenic. Therefore, FDA concludes that there is insufficient information in the current record to determine whether the ingestion of egg white lysozyme elicits an allergic response when consumed by individuals who are sensitive to egg whites. Accordingly, FDA is proposing labelling to alert such individuals to the presence of egg white lysozyme in cheese. Such labelling also would alert the sensitive population to the possible presence of source-derived proteins other than lysozyme in the enzyme preparation. To give interested persons an opportunity to comment on this condition of use required for GRAS status, FDA is issuing this tentative final rule.

Products Covered: Food additives

Regulation Type: Regular notification

Distribution date: 24 February 1998

The Food Safety and Inspection Service (FSIS) is revising its policy regarding Agency approval of non-food compounds and proprietary substances prior to use in official meat and poultry establishments. The compounds and substances currently subject to prior approval include maintenance and operating chemicals (sanitizers, cleaning compounds, water treatments, lubricants, and pesticides) and proprietary food processing chemicals (branding inks, scalding agents, rendering agents, and denaturants). FSIS recently proposed to eliminate the sanitation regulations requiring prior approval for some of these compounds and substances (contained in 9 CFR Parts 308 and 381, Sub-part H). FSIS now is announcing that it is eliminating the prior approval system for all-non-food compounds and proprietary substances and specifically requests comment on alternatives to the current prior approval system.

Products Covered: Meat and poultry establishments

Regulation Type: Regular notification