Regulations Under the Tea Importation Act; Tea Standards

DEPARTMENT OF HEALTH AND HUMAN SERVICES

21 CFR Part 1220

[Docket No. 94N-0148]

Regulations Under the Tea Importation Act; Tea Standards

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the

establishment of tea standards for the year beginning May 1, 1994, and

ending April 30, 1995. The tea standards are provided for under the Tea

Importation Act (the Act). The Act prohibits the importation of a tea

that is inferior to the annual tea standard. Under the Act, the

importation of a tea may be withheld until FDA examines the tea and is

sure that it complies with the annual standard.

DATES: Effective May 1, 1994; written comments by August 10, 1994.

ADDRESSES: Submit written comments to the Docket Management Branch

(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Michelle A. Smith, Center for Food

Safety and Applied Nutrition (HFS-158), Food and Drug Administration,

200 C St. SW., Washington, DC 20204, 202-205-5099.

SUPPLEMENTARY INFORMATION: Because of the unique nature of the

decisionmaking process for establishing annual standards for tea, the

procedural protections that are part of this process, and the short

period within which standards must be set, FDA has never, since the

enactment in 1897 of the Act (21 U.S.C. 41), used notice and comment

rulemaking for tea standards.

Each final rule setting the standards is based on the

recommendations of the Board of Tea Experts (the board), which is

comprised of tea experts who are representative of the tea trade. The

board selects standards each year according to the provisions of the

Act. The board bases its selection on tea samples submitted by members

of the tea trade to the board. Relying primarily on organoleptic

examination, the board selects one tea to represent the standard for

each major type of tea imported into the United States. In choosing a

standard, the board tries to select one at least equal in quality to

that of the previous year. The Act prohibits the importation of a tea

that is inferior to the annual tea standard. Under the Act, the

importation of a tea may be withheld until FDA examines the tea and is

sure that it complies with the annual standard.

The annual meeting of the board is open to the public and is

announced in advance in the Federal Register. At the annual meeting any

interested person may present data, information, or views orally or in

writing regarding new standards.

The annual tea standards are prepared and submitted to the

Secretary of Health and Human Services by the board (21 CFR 1220.41).

Should a tea importer be dissatisfied with an FDA tea examiner's

rejection of a shipment of tea, the importer can refer its complaint to

the U.S. Board of Tea Appeals and then to the U.S. Court of Appeals.

FDA is unaware of any complaints or arguments having ever occurred

concerning a designated standard, despite the many years since the

enactment of the Act.

FDA concludes that notice and comment rulemaking to set tea

standards is impracticable, contrary to the public interest, and

unnecessary by virtue of the factors discussed above, i.e., the unique,

longstanding procedures that apply to establishing a standard, the fact

that standards are based principally on organoleptic examinations by

tea experts, the public participation opportunities already provided,

and the timeframes required for issuing annual standards. Hence, the

agency is not following notice and comment rulemaking procedures in

establishing the final tea standards for 1994.

Environmental Impact

The agency has determined under 21 CFR 25.24(b)(1) that this action

is of a type that does not individually or cumulatively have a

significant impact on the human environment. Therefore, neither an

environmental assessment nor an environmental impact statement is

required.

Analysis of Impacts

FDA has examined the impacts of the final rule under Executive

Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).

Executive Order 12866 directs agencies to assess all costs and benefits

of available regulatory alternatives and, when regulation is necessary,

to select regulatory approaches that maximize net benefits (including

potential economic, environmental, public health and safety, and other

advantages; distributive impacts; and equity). The agency believes that

this final rule is consistent with the regulatory philosophy and

principles identified in the Executive Order. In addition, the final

rule is not a significant regulatory action as defined by the Executive

Order and so is not subject to review under the Executive Order.

The impact of this rule on small entities, including small

businesses, was reviewed in accordance with the Regulatory Flexibility

Act (Pub. L. 96-354) (5 U.S.C. 601). FDA has concluded that this action

will not result in a significant economic impact on a substantial

number of small entities. Therefore, FDA certifies, in accordance with

section 605(b) of the Regulatory Flexibility Act, that no significant

economic impact on a substantial number of small entities will derive

from this action.

Interested persons may, on or before August 10, 1994, submit to the

Dockets Management Branch (address above) written comments regarding

this regulation. Two copies of any comments are to be submitted, except

that individuals may submit one copy. Comments are to be identified

with the docket number found in brackets in the heading of this

document. Received comments may be seen in the office above between 9

a.m. and 4 p.m., Monday through Friday. Any changes in this regulation

justified by such comments will be the subject of a further amendment.

List of Subjects in 21 CFR Part 1220

Administrative practice and procedure, Customs duties and

inspection, Imports, Public health, Tea.

Therefore, under the authority delegated to the Secretary of Health

and Human Services by the Tea Importation Act and under authority

delegated to the Commissioner of Food and Drugs, 21 CFR part 1220 is

amended as follows:

PART 1220--REGULATIONS UNDER THE TEA IMPORTATION ACT

1. The authority citation for 21 CFR part 1220 continues to read as

follows:

Authority: 21 U.S.C. 41-50; 19 U.S.C. 1311.

2. Section 1220.40 is amended by revising paragraph (a) to read as

follows:

Sec. 1220.40 Tea standards.

(a) Samples for standards of the following teas, prepared,

identified, and submitted by the Board of Tea Experts on February 25,

1994, are hereby fixed and established as the standards of purity,

quality, and fitness for consumption under the Tea Importation Act for

the year beginning May 1, 1994, and ending April 30, 1995:

(1) Black Tea (for all teas except those from the People's Republic

of China (China), Taiwan (Formosa), Iran, Japan, Russia, Turkey, and

Argentina).

(2) Black Tea (for Argentina teas).

(3) Black Tea (for teas from the People's Republic of China

(China), Taiwan (Formosa), Iran, Japan, Russia, and Turkey).

(4) Green Tea (of all origins).

(5) Formosa Oolong.

(6) Canton Oolong (for all Canton types from the People's Republic

of China (China) and Taiwan (Formosa)).

(7) Scented Black Tea.

(8) Spiced Tea.

These standards apply to tea shipped from abroad on or after May 1,

1994.

* * * * *

Dated: June 30, 1994.

Michael R. Taylor,

Deputy Commissioner for Policy.

[FR Doc. 94-16616 Filed 7-8-94; 8:45 am]

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