[Federal Register Volume 61, Number 26 (Wednesday, February 7, 1996)]
[Proposed Rules]
[Pages 4597-4598]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-2595]



=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1220

[Docket No. 96N-0011]


Tea Importation Act; Tea Standards

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing how it 
intends to implement the Tea Importation Act (the Act) in the wake of 
the agency's appropriation for fiscal year (FY) 1996, which provides 
that none of the funds appropriated may be used to operate the Board of 
Tea Experts (the board). Without a board to provide recommendations for 
standards of purity, quality, and fitness for consumption of imported 
teas, FDA has decided to solicit public recommendations for the tea 
standards that will be effective beginning May 1, 1996. In addition, 
FDA requests comments on the appropriateness of this approach to 
setting such standards.

DATES: Written comments and other material considered relevant, 
including samples that the agency may use as standards, by April 8, 
1996. FDA proposes that any final standards that are adopted in this 
proceeding will be effective on May 1, 1996.

ADDRESSES: Submit written comments and any tea samples to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 12420 
Parklawn Dr., rm. 1-23, 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: Section 3 of the Act (21 U.S.C. 43) states:
    The Secretary of [Health and Human Services], upon the 
recommendation of the board of experts provided in section 2 of this 
title, shall fix and establish uniform standards of purity, quality, 
and fitness for consumption of all kinds of tea imported into the 
United States, and shall procure and deposit in the customhouses of 
the ports of New York, Chicago, San Francisco, and such other ports 
as he may determine, duplicate samples of such standards.
Under the Act and the regulations that FDA has adopted to implement it, 
FDA sets such standards annually (see 21 U.S.C. 42 and 21 CFR 1220.40). 
No tea that is inferior in purity, quality, or fitness for consumption 
to the standard established by FDA may be brought into this country (21 
U.S.C. 41).
    Public Law 104-37, which contains FDA's appropriation for FY 1996, 
states that: ``None of the funds appropriated or made available to the 
Food and Drug Administration in this Act shall be used to operate the 
Board of Tea Experts.'' This provision creates a significant problem 
for the agency since members of the board cannot be appointed, nor its 
activities supported by FDA. Nonetheless the Act remains in effect. 
Thus, FDA has a continuing obligation to implement it. This obligation 
is underscored by the fact that Congress rejected a broader limitation 
on the agency's ability to expend funds to implement the Act that 
appeared in the version of the appropriations bill that passed the 
Senate (see H. Rept. 104-268, 104th Cong., 1st sess. 38 (1995)). 
However, without the benefit of the advice of the board, the agency is 
faced with the question of how it will arrive at the standards required 
under the Act for imported teas.
    In considering this question, FDA identified three options. First, 
it could do nothing to implement the Act. The agency rejected this 
option because it would be inconsistent with the apparent intent of 
Congress, and because it would mean that it would ostensibly be 
unlawful to bring or import into the United States any merchandise 
identified as tea. Even though the agency could, as an exercise of its 
enforcement discretion, do nothing about the latter fact, FDA considers 
it unfair and unwise to allow such a situation to emerge. Thus, the 
agency considers it incumbent on itself to continue to implement the 
Act in a manner that is consistent with law.
    The second option that the agency identified was to ask the 
Department of Health and Human Services, of which FDA is a part, to 
operate the board with funds not appropriated in Pub. L. 104-37. The 
agency rejected this option because it is not consistent with the 
spirit of Congress's action, and because the Department is likely to 
have little ability to assume this financial and resource obligation.
    The third option that FDA considered was to substitute public input 
for the recommendations of the board. This option is not inconsistent 
with the law. The requirement in 21 U.S.C. 43 is that the Secretary 
(and, by delegation, FDA) fix and establish standards for teas. While 
the law provides that the board is to provide recommendations to FDA, 
there is nothing in the Act that says that the agency can only 
establish such standards based on the board's recommendations. Thus, 
the agency is not precluded from relying on other sources of 
information. The agency considers it likely that the information that 
it receives in response to a request for comments will allow it to set 
appropriate standards for tea. Moreover, once the agency sets such 
standards, tea can continue to come into this country lawfully, limited 
only by the standards that FDA sets.
    Based on these considerations, FDA is seeking public comment on the 
standards of purity, quality, and fitness for consumption of tea that 
it is to set under 21 U.S.C. 43 for the year beginning on May 1, 1996. 
FDA requests that interested persons submit all material that they 
consider relevant, including samples that the agency may use as 
standards. FDA will evaluate the information that it receives, and, 
based on that evaluation, it intends to arrive at the standards that 
will apply to tea shipped from abroad after May 1, 1996, until April 
30, 1997.
    In addition to comments on what the standards should be, FDA 
solicits comment on the process that it has instituted. FDA solicits 
comments on its 

[[Page 4598]]
tentative view that this course of action is consistent with both the 
Act and Pub. L. 104-37. Any comments that disagree should set forth the 
basis for the view. The agency also solicits comments on whether there 
are any other options that the agency can follow that are preferable to 
the one that it has tentatively decided to pursue and yet that are 
still consistent with the two laws in question.
    Dependent on the comments, information, and other material 
(including tea samples) submitted in response to this proposal, FDA is 
hopeful of being able to proceed directly to a final rule that 
establishes the applicable tea standards.

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 effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

Analysis of Impacts

    FDA has examined the impact of this proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354). 
Executive Order 12866 directs Federal agencies to assess the 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 
effects; distributive impacts; and equity). According to Executive 
Order 12866, a regulatory action is ``economically significant'' if it 
meets any one of a number of specified conditions, including having an 
annual effect on the economy of $100 million or adversely affecting in 
a material way a sector of the economy, competition, or jobs. A 
regulation is considered ``significant'' under Executive Order 12866 if 
it raises novel legal or policy issues. The Regulatory Flexibility Act 
requires Federal agencies to minimize the economic impact of their 
regulations on small businesses.
    FDA finds that this proposed rule is neither an economically 
significant nor significant regulatory action as defined by Executive 
Order 12866. In compliance with the Regulatory Flexibility Act, FDA 
certifies that this proposed rule, if promulgated, will not have a 
significant impact on a substantial number of small businesses.
    Under the current standard setting procedure, the public provides 
relevant information and material, such as tea samples, to the board, 
which then makes recommendations to FDA. Based on these 
recommendations, FDA sets tea standards for that year. Under the 
proposed system, the public may send information and material directly 
to FDA, which will set tea standards for that year without the 
recommendations of the board. This change in the standard setting 
process is not expected to lead to any additional compliance costs.
    The primary benefit of the proposed method of setting tea standards 
is that it allows those standards to be set in the absence of 
recommendations by the board. FDA is required to set tea standards 
under Section 43 of the Act (21 U.S.C. 43).
    FDA requests comments on the economic consequences of the proposed 
method of setting tea standards, the various ways in which tea samples 
and other information submitted to FDA may best be used to set tea 
standards, and on means by which the costs of the proposed standard 
setting process may be minimized and the benefits maximized.

Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no 
reporting, recordkeeping, labeling, or other third party disclosure 
requirements; thus, there is no ``information collection'' 
necessitating clearance by the Office of Management and Budget.
    Interested persons may, on or before April 8, 1996, 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. FDA believes that 60 days is an 
appropriate amount of time for meaningful comments to be submitted and 
for the agency to meet its statutory obligation to establish new 
standards for imported tea by May 1, 1996.

    Dated: January 31, 1996.
William K. Hubbard,
Associate Commisioner for Policy Coordination.
[FR Doc. 96-2595 Filed 2-2-96; 10:52 am]
BILLING CODE 4160-01-F