Citizen Petition Research Articles

BGH fracas erupts again in U.S., Canada

The Center for Food Safety, a Washington, D.C.-based advocacy group, and 20 other health, environmental, and agricultural organizations last week filed a citizen petition with the Food & Drug Administration calling for a reversal of the agency's 1993 approval of Posilac, Monsanto's bovine growth hormone (BGH) product. The petitioners assert that evidence not fully considered by FDA when it approved Posilac—which is injected into cows to increase their milk production—indicates that more human health testing is needed. FDA has to respond to the petition within 180 days. A Monsanto spokesman says the petition contains no new information, that it is a continuation of the opposition to BGH by a variety of activists, and that the safety of BGH for both humans and cows has been thoroughly addressed and confirmed by many regulatory bodies in the U.S. and overseas. Monsanto's BGH is a slightly modified, bioengineered version of a natural protein produced in the pituitary gland ...

Genentech, Inc.'s Citizens Petition Requesting an Advisory Opinion, the Establishment of Required Procedures and an Administrative Stay

Genentech, Inc.'s Citizens Petition Requesting an Advisory Opinion, the Establishment of Required Procedures and an Administrative Stay

BABIES' SEATS ARE AIR SAFETY ISSUE

The Federal Aviation Administration requires that every airline passenger wear a seat belt during takeoffs and landings—everyone, that is, except children under the age of 2. Parents have two options: They can hold children in their laps, or since 1982 they have been allowed to provide their own Government-certified child's safety seat. But very few parents use the safety seats on board because it generally means having to buy a ticket for children who would otherwise fly free of charge. Given the F.A.A. policy, travelers may have assumed that unrestrained children face little safety risk on aircraft. In fact, an unrestrained passenger of any age faces a higher risk of death or injury in a survivable crash or severe turbulence than passengers who are strapped into safety seats or belts. Three years ago the agency denied a citizen's petition to require safety restraints for very young children. To determine the cost of the proposed regulation, however, the F.A.A. estimated that 1 percent of the 280 million passengers, or 28,000, were under the age of 2 in 1982. Consequently, their parents would have had to spend $56 million on airline tickets to accommodate child safety seats, which might have prevented in the agency's calculation, a loss of life valued at $500,000.

To Switch or Not to Switch? GRAS/GRAE is Still the Question

In the 1938 Act, the Congress clearly had in mind a system under which a drug would move over time from new to GRAS/GRAE. The reasons that the movement is slow, sporadic, and inconsistent involve the opposing forces acting consistently with their natures. The FDA resists relinquishing authority where it feels it may want it in the future. The companies that have obtained premarket approval are totally resistant to the notion that competitors might not have to overcome the same barriers. As a result, the inertia of these combined forces can be formidable opposition to the desired movement of Rx drugs to general recognition status. Nevertheless, the expectations and presumptions of the law are clear that drug products should move over time to GRAS/GRAE status. Unless there are further fundamental changes in the law, the dynamics of competition will make GRAS/GRAE citizen's petitions and declaratory judgment actions more important to the Rx-to-OTC switches of the next decade. The base proposition for many of...

Adding Another Foreign Language to the Secondary School Program

YEAR in and year out, a number of administrators are faced with the problem of whether to add another foreign language to their program. Although the impulses to expansion are varied, the principles involved are almost always the same. In formulating a typical problem and in presenting the principles to be applied in solving it, the assumption is made that a group of interested citizens who are native speakers of a less-commonly-offered modern foreign language have asked the administrators of a goodsized school system to add the study of their language to the grade 9-12 curriculum. It is understood that the additional language will enjoy the same status as the presently established languages, that offering it is in no way intended to cater to pupils of a particular intellectual strength, whether low or high. It is also understood that every foreign language offering in the curriculum is to constitute a minimum sequence of four years and four levels ending with the completion of grade 12, The position adopted here is that the solution of the problem should take into consideration the following questions, together with the suggested answers which are held to constitute the application of reasonable, workable principles. A grade 7-12 five-level sequence is mentioned incidentally. 1. Does the school system have sufficient numbers of well-motivated and able pupils to support the petition of the interested citizens and thus to warrant the establishment of the proposed language as a minimum four-year, four-level sequence ending with the completion of grade 12? The likelihood of support of the proposed language by interested and able pupils willing to study the language for a minimum of four years and four levels (or six years and five levels) through grade 12 is far more important than the support of a linguistic or ethnic segment of the adult community. Indications of pupil support can be obtained through preregistration of 8th grade pupils at the middle of the academic year, administration of aptitude tests, application of locally devised criteria, and a consideration of enrollments in current course-offerings. 2. Can the school system be sure of having at the appropriate grade-levels fully competent teachers of the proposed language to establish and 245

XXIII. A Petition of the Citizens of Winchester, anno 1450, to King Henry VI. concerning the ruinous State of their City, &c. Ex Rot. Turr. London

Besechess fulle humblie your humble trew leige men, the maire, balifs, and comonalitie of your pouere citee of Wynchestre; that, whereas they have ben charged to bere the fee ferme of your said citee, whiche draweth yerlyee to the somme of an cxii marc; and bere also to the maister of the Hospitalle of Marie Maudelene beside Wynchestre lx s. also when the xv penny or taxe is graunted to your highnesse, it draweth to the somme of li l.. x s. iv d. withyne the said citee; the whiche, whenne it is levable, sum oon man in the said citee is sette unto iiii marc, and sum v marc, because your said citee is desolate of peple; also expens of Burges of the said citee comyng to your parlements, draweth to iiii s. by the daye; for the which said fee ferme so to be paid, your bailiffs have little or nought of certigntee to arayse it of, but oonly of casualtees, and yerelie lesen in payment of the said fee ferme xl l. or more; for which causes above said, and also for the grete charges and dayelie costes the which your said pouere citee berethe, abowte the enclosyng and meerage of your said citee, it is become right desolate, in so much as many notable parsons ben withdrawen out of the said citee for the causes above said.