noting that legislative regulations properly issued by agencies “have the force and effect of legislation"
How later courts described this case
- noting that legislative regulations properly issued by agencies “have the force and effect of legislation"
- where court found that since FDA was not instructed by statute to define term, regulation defining the term was merely interpretive
- regulations implementing a statutory mandate “have the force and effect of legislation, and may not be set aside because a court would have read the statutory mandate differently.”
- FDA construction of term within Food, Drug, and Cosmetic Act, 21 U.S.C. § 321(s)
Written by the judges who cited it.
The opinion
PREGERSON, Circuit Judge,
dissenting:
The Supreme Court stated in Federal Election Commission v. Democratic Senatorial Campaign Committee, 454 U.S. 27, 31-32 , 102 S.Ct. 38, 42 , 70 L.Ed.2d 23 (1981) that the “interpretation put on a statute by the agency charged with administering it is entitled to deference.” An agency’s interpretation will be upheld if its construction of the statute is “sufficiently reasonable.” Id. at 39 , 102 S.Ct. at 46 . “To satisfy this standard it is not necessary for a court to find that the agency’s construction was the only reasonable one or even the reading the court would have reached if the question initially had arisen in a judicial proceeding.” Id. See also Horizon Mutual Savings Bank v. Federal Savings & Loan Insurance Corp., 674 F.2d 1312, 1316 (9th Cir.1982).
The FDA’s regulation that limits the common usage test to use in the United States is a reasonable interpretation of the statute. The purpose of the amendment was to ensure that additives in foods consumed by Americans are safe to eat, taking into consideration such factors as the other items in the consumer’s diet and the consumer’s life span. S.Rep. No. 2422, 85th Cong., 2nd Sess. 3, reprinted in 1958 U.S. Code Cong. & Ad.News 5300, 5305. It is impossible to know if an additive used by a large number of persons in a foreign country is safe unless that country has an accurate reporting system. The problem is further complicated by the fact that the harmful effect of some additives may not come to light until after a lengthy incubation period.
In view of the legislative intent to ensure safe foods for Americans, I think that the *1392 FDA’s regulation was sufficiently reasonable and, therefore, should be upheld.