Grandfather clause

Under current regulations, chemicals allowed for use in various European countries (Table 3) are either fully Hcensed for aquacultural use (oxytetracycline, oxolinic acid) or can be prescribed by veterinarians if they are Hcensed for use on other food animals (14—16). In addition, previously unHcensed chemicals that are appHed to the water (topicals) may now be used under a grandfather clause if no one questions their safety. The question of whether a chemical is a medicine or a pesticide has also been addressed. Eor example, dichlorvos (Nuvan 500 EC) was initially designated as a pesticide in the United Kingdom, but was later categorized as a medicine. A similar product, trichlorfon (Masoten), was treated the same way in the United States. 

There is also no grandfather clause for studies completed or in progress or in the extant literature. Unfortunately, no one considered the costs of repeating everything that did not anticipate their good ideas. An additional unforeseen consequence is that repeated studies will have to compete directly with new initiatives for program space and resources. Delays will result in economic losses to producers and manufacturers, and in increased costs to consumers. Apparently, none of these points are considered important enough to make it into a cost/benefit statement. 

The main area of enforcement of this CPG comes from the no grandfathering clause. 

This clause applies to legacy systems and the electronic records stored by these systems. The no grandfathering clause indicates that Part 11 provisions relating to record creation do not cover electronic records that are created before the effective date of the rule. These records would not need to be retrospectively altered. 

Section 8 of the DSHEA is a grandfathering clause. Substances in use prior to October 15, 1994 are not subject to the standard of reasonably expected to be safe. Substances marketed after this date are considered new dietary ingredients. Unless the dietary supplement was present in the food supply as an article used for food in a form in which the food has not been chemically altered, the manufacturer must notify the FDA at least 75 days before marketing the product. The manufacturer must supply the FDA with information based on history of use or other evidence of safety to support that the product will reasonably be expected to be safe for the stated use. There are no guidelines in the DSHEA for what constitutes history of use or other evidence of safety. - ... 

Two logistical aspects of the Privacy Rule authorization should be noted. First, grandfather clauses will be implemented for research studies that began prior to the Privacy Rule s compliance date (April 14, 2003). Second, it should be noted that an IRB may approve a waiver of authorization if the use or disclosure of PHI would involve no more than minimal risk to subjects and if the IRB judges it impractical to conduct the research without the waiver and without access to the PHI. 

Today the scientific evidence required to show GRAS status is equal in extent to the documentation which must be submitted in support of a food additive petition (12). However, there is a grandfather clause in the case of a substance used in food prior to January 1, 1958 safety may be shown either through scientific procedures or through experience based on common use in food (11). 

Q. Is there a grandfather clause for horns on construction equipment ... 

A. Section 1926.601(a)(3) requires all motor vehicles to be equipped with an adequate audible warning device at the operator s station and in an operable condition. Section 1926.602(a)(9)(l) covers material handling equipment and requires all bidirectional machines, such as rollers, compactors, front-end loaders, bulldozers, and similar equipment, to be equipped with a horn, distinguishable from the surrounding noise level, which shall be operated as needed when the machine is moving in either direction. The horn is required to be maintained in an operative condition. The construction standards do not contain a grandfather clause for the use of horns. 

ANSI/ISA-84.01-1996 has been retired and replaced with ANSI/ISA-84.00.01-2004 Parts 1-3 (lEC 61511 Mod). The new standard is the ANSI/ISA adoption of the international standard, lEC 61511, and includes one additional clause, a grandfather clause covering existing SIS (ANSI/ISA-84.00.01-2004 Part 1 Clause 1.0 y). 

Clause 3 and Annex A specifically address the grandfather clause and provide guidance on the evaluation of existing SIS. 

The grandfather clause (ANSI/ISA-84.00.01-2004-1 Clause 1.0 y) states For existing SIS designed and constructed in accordance with codes, standards, or practices prior to the issuance of this standard (e.g. ANSI/ISA-84.01-1996), the owner/operator shall determine that the equipment is designed, maintained, inspected, tested, and operating in a safe manner."... 

The grandfather clause releases the owner/operator from the design and construction requirements of ANSI/ISA-84.00.01-2004-1 for existing installations if they can demonstrate these criteria. This leads to questions regarding how to demonstrate compliance with the grandfather clause and at what point modifications to the process or the SIS have become significant enough to warrant reassessment of the adequacy of the SIS. 

The owner/operator should be aware that the grandfather clause only addresses the SIS design and construction. The other requirements of ANSI/ISA-84.00.01-2004-1 should still be implemented, as appropriate. Documentation, procedures, training, testing, and auditing requirements of ANSI/ISA-84.00.01-2004-1 are applicable to all SIS, whether existing or new. 

It is important for the owner/operator to develop an approach for addressing existing SIS. It is the responsibility of the owner/operator to determine that existing SIS meet the intent of the grandfather clause and to document the operating, testing, inspection and maintenance conditions under which this remains true. 

There are a variety of methods that can be employed to determine and document the applicability of the grandfather clause. ISA-TR 84.00.04-1 Annex A is a collection of methods used by various owners/operators on the ISA84 committee. 

Owners/operators of grandfathered SIS (i.e., those SIS that have been determined to meet the intent of ANSI/ISA-84.00.01-2004-1 Clause I.Oy) should acknowledge that this status does not provide an indefinite shield against the full requirements of ANSI/ISA-84.00.01-2004-1. The grandfather clause does not protect any owner/operator from the OSH Act General Duty clause, which requires that owners/operators provide a safe working environment. And US-OSHA has already stated in their letter to ISA, dated March 23, 2000, that The employer may be in violation of the General Duty Clause, Section 5 (a)(1) of the OSH Act, if SIS are utilized which do not conform with S84.01 [1996] and hazards exist related to the SIS which could seriously harm employees. ... 

Even if an existing SIS has been found to meet the intent of the grandfather clause, changes to the SIS or the process to which it is providing protection may trigger the need to formally re-evaluate its grandfather status. Therefore, MOC procedures should specifically address the issue of SIS modification. An MOC review should be conducted whenever the change potentially affects the process risk. 

Clauses A.3.1 through A.3.8 provide eight different approaches used by owners/operators in the evaluation of the applicability of the grandfather clause. These methods are provided for illustrative purposes only. Owners/operators are responsible for developing a method for use at their facilities. 

Step 1. Define process facility grandfather clause application rules. 

After reviewing ISA-TR84.00.04-1 Clause 3.0, the owner/operator establishes ground mies that are to be implemented whenever existing SIS are analyzed for grandfather clause application. An example of ground rules is provided in Table A.1. 

GR-2 The plant processes to be considered for grandfather clause implementation are process sector-related (e.g., continuous and batch) processes only. 

Step 4. Analyze the SIF design basis and determine if it meets the grandfather clause ground rules. 

If the SIF is designed, installed, maintained, inspected, tested, and operating according to the design basis, the grandfather clause is applicable. 

Another approach to SIS evaluation is the development of a checklist based upon ANSI/ISA-84.00.01-2004-1 requirements. The checklist should address major philosophical and technology issues defined in ANSI/ISA-84.00.01-2004-1. Any no answers (e.g., response other than a") would exclude the SIS under consideration from the grandfather clause. A few examples of the types of questions that could be addressed in the checklist are provided below. 

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