[House Report 104-436]
[From the U.S. Government Publishing Office]
[COMMITTEE PRINT]
Union Calendar No. 211
104th Congress, 1st Session - - - - - - - - - - House
Report 104-436
THE FDA FOOD ADDITIVE REVIEW PROCESS: BACKLOG AND FAILURE TO OBSERVE
STATUTORY DEADLINE
__________
FOURTH REPORT
by the
COMMITTEE ON GOVERNMENT
REFORM AND OVERSIGHT
together with
ADDITIONAL VIEWS
December 21, 1995.--Committed to the Committee of the Whole House on
the State of the Union and ordered to be printed
COMMITTEE ON GOVERNMENT REFORM AND OVERSIGHT
WILLIAM F. CLINGER, Jr.,
Pennsylvania, Chairman
BENJAMIN A. GILMAN, New York
DAN BURTON, Indiana
J. DENNIS HASTERT, Illinois
CONSTANCE A. MORELLA, Maryland
CHRISTOPHER SHAYS, Connecticut
STEVEN SCHIFF, New Mexico
ILEANA ROS-LEHTINEN, Florida
WILLIAM H. ZELIFF, Jr., New
Hampshire
JOHN M. McHUGH, New York
STEPHEN HORN, California
JOHN L. MICA, Florida
PETER BLUTE, Massachusetts
THOMAS M. DAVIS, Virginia
DAVID M. McINTOSH, Indiana
JON D. FOX, Pennsylvania
RANDY TATE, Washington
DICK CHRYSLER, Michigan
GIL GUTKNECHT, Minnesota
MARK E. SOUDER, Indiana
WILLIAM J. MARTINI, New Jersey
JOE SCARBOROUGH, Florida
JOHN B. SHADEGG, Arizona
MICHAEL PATRICK FLANAGAN, Illinois
CHARLES F. BASS, New Hampshire
STEVEN C. LaTOURETTE, Ohio
MARSHALL ``MARK'' SANFORD, South
Carolina
CARDISS COLLINS, Illinois ROBERT L. EHRLICH, Jr., Maryland
HENRY A. WAXMAN, California
TOM LANTOS, California
ROBERT E. WISE, Jr., West Virginia
MAJOR R. OWENS, New York
EDOLPHUS TOWNS, New York
JOHN M. SPRATT, Jr., South Carolina
LOUISE McINTOSH SLAUGHTER, New York
PAUL E. KANJORSKI, Pennsylvania
GARY A. CONDIT, California
COLLIN C. PETERSON, Minnesota
KAREN L. THURMAN, Florida
CAROLYN B. MALONEY, New York
THOMAS M. BARRETT, Wisconsin
GENE TAYLOR, Mississippi
BARBARA-ROSE COLLINS, Michigan
ELEANOR HOLMES NORTON, District of Columbia
JAMES P. MORAN, Virginia
GENE GREEN, Texas
CARRIE P. MEEK, Florida
CHAKA FATTAH, Pennsylvania
BILL BREWSTER, Oklahoma
TIM HOLDEN, Pennsylvania
------
BERNARD SANDERS, Vermont (Independent)
James L. Clarke, Staff Director
Kevin Sabo, General Counsel
Judith McCoy, Chief Clerk
Bud Myers, Minority Staff Director
_________________________________________________________________
Subcommittee on Human Resources and Intergovernmental Relations
CHRISTOPHER SHAYS, Connecticut,
Chairman
MARK E. SOUDER, Indiana
STEVEN SCHIFF, New Mexico
CONSTANCE A. MORELLA, Maryland
THOMAS M. DAVIS, Virginia
DICK CHRYSLER, Michigan
WILLIAM J. MARTINI, New Jersey
JOE SCARBOROUGH, Florida
MARSHALL ``MARK'' SANFORD, South
EDOLPHUS TOWNS, New York Carolina
TOM LANTOS, California
BERNARD SANDERS, Vermont (Ind.)
THOMAS M. BARRETT, Wisconsin
GENE GREEN, Texas
CHAKA FATTAH, Pennsylvania
HENRY A. WAXMAN, California
Ex Officio
WILLIAM F. CLINGER, Jr.,
CARDISS COLLINS, Illinois Pennsylvania
Lawrence Halloran, Staff Director
Anne Marie Finley, Professional
Staff Member
Thomas Costa, Clerk
Cheryl Phelps, Minority
Professional Staff
(ii)
LETTER OF TRANSMITTAL
----------
House of Representatives,
Washington, DC, December 21, 1995.
Hon. Newt Gingrich,
Speaker of the House of Representatives,
Washington, DC.
Dear Mr. Speaker: By direction of the Committee on
Government Reform and Oversight, I submit herewith the
committee's fourth report to the 104th Congress.
William F. Clinger, Jr.,
Chairman.
(iii)
C O N T E N T S
----------
Page
I. Summary....................................................... 1
II. Background................................................... 2
III. Findings.................................................... 6
IV. Recommendations.............................................. 10
VIEWS
Additional views of Hon. David M. McIntosh and Hon. Mark E.
Souder......................................................... 14
(v)
Union Calendar No. 211
104th Congress Report
HOUSE OF REPRESENTATIVES
1st Session 104-436
_______________________________________________________________________
THE FDA FOOD ADDITIVE REVIEW PROCESS: BACKLOG AND FAILURE TO OBSERVE
STATUTORY DEADLINE
_______
December 21, 1995.--Committed to the Committee of the Whole House on
the State of the Union and ordered to be printed
_______________________________________________________________________
Mr. Clinger, from the Committee on Government Reform and Oversight,
submitted the following
FOURTH REPORT
On December 14, 1995, the Committee on Government Reform
and Oversight approved and adopted a report entitled ``The FDA
Food Additive Review Process: Backlog and Failure To Observe
Statutory Deadline.'' The chairman was directed to transmit a
copy to the Speaker of the House.
I. SUMMARY
Food additive petitions must be reviewed and acted upon by
the Food and Drug Administration (FDA) ``not more than 180 days
after the date of filing of the petition.'' \1\ The statutory
deadline is not being met and statutory changes are needed to
establish more realistic and binding time frames for petition
reviews. The regulatory scheme in the United States for food
additive review is dysfunctional, and as a result, the American
consumer and patient are deprived of technologies that will
increase the variety and nutritional benefits of foods, improve
diet and advance public health.
\1\ 21 U.S.C. 348 (c) (2).
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Findings:
1. FDA does not meet the 180 day statutory deadline to
review and make a decision on food additive petitions.
2. There were 295 pending food additive petitions (direct,
indirect, and generally recognized as safe (GRAS)), some of
which were filed in the 1970s, as of June 22, 1995.
3. The lack of fixed deadlines and the increased scientific
ability to detect and measure potential hazards have resulted
in a review process that is risk-averse.
4. FDA is reluctant to decline incomplete or inadequate
petitions, and consequently, allows incomplete and inadequate
petitions to remain under review at FDA for more than 180 days.
5. FDA has committed insufficient resources to its food
additive review responsibilities.
6. FDA does not set food additive petition review
priorities appropriately.
7. FDA's failure to expeditiously review food additive
petitions has stifled innovation and introduction of new
ingredients by the food industry.
8. A petition review process with no fixed deadlines can be
manipulated for anti-competitive purposes.
9. FDA does not make sufficient use of independent
scientific resources for food additive petition review.
Recommendations:
1. Congress should amend the Federal Food, Drug and
Cosmetic Act review period for food additive petitions, from
180 to 360 days for the most scientifically complex reviews,
and the deadline should be strictly observed by FDA.
2. The FDA should recognize that the approval of useful and
safe new products can be as important to the public health as
preventing the marketing of harmful or ineffective products.
3. The FDA should eliminate the backlog of pending food
additive petitions within one year by reallocating the
necessary agency resources.
4. The FDA should utilize outside expertise in its
evaluation of food additive petitions but retain authority for
petition approval.
5. The relevance of the Delaney clause should be studied in
view of modern scientific standards so t hat better
distinctions can be made between nominal hazards and actual
risks.
6. The FDA should amend the review process to prohibit
anonymous submissions of data or comments.
II. BACKGROUND
The Human Resources and Intergovernmental Relations (HRIR)
Subcommittee began an oversight investigation into the delays
in the Food and Drug Administration's (FDA) review and decision
making on food additive petitions in April, 1995. This was the
first comprehensive oversight investigation into the FDA's
management of the food additives program since the food
additive amendments were passed in 1958.
The Subcommittee sent document requests to FDA on April 13,
April 17, and June 12, 1995. Oversight briefings with FDA were
held May 23, June 5, June 9, June 16, June 19, and June 21,
1995. Academicians, former FDA Center for Food Safety and
Applied Nutrition (CFSAN) employees, food manufacturers, trade
associations, food scientists, and consumer groups were
interviewed by the subcommittee staff. HRIR subcommittee
hearings were held on June 22 and June 29, 1995.
After the June 22 hearing, a letter from Chairman
Christopher Shays and Ranking Member Edolphus Towns was sent to
Health and Human Services (HHS) Secretary Donna E. Shalala on
June 26, 1995, requesting a legislative proposal that would
establish a statutory standard which the FDA could meet in its
review of food additive petitions. A follow up letter was sent
on August 29, 1995, after no response was received from HHS. A
response was received on September 13, 1995. FDA briefed
Subcommittee staff on October 2, 1995, on the agency's
legislative proposal to rectify the food additive review
delays.
The FDA proposes a statutory change which would extend the
review period from the current 180 days to 360 days. The agency
is committed to reviewing 90% of the petitions within 180 days
and proposes administrative performance goals to keep no more
than 10% of petitions under review for up to 360 days.
The agency also supports statutory changes which would
effect streamlining of the rulemaking process for both food and
color additives, increased use of outside experts for review of
food and color additive petitions (through amendment of the
Federal Advisory Committee Act \2\ (FACA)) and conforming
amendments for color additives to harmonize deadlines of both
food and color additive petitions.
\2\ (5 U.S.C. App.) P.L. 92-463, 86 Stat. 770, Oct. 6, 1972.
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The agency will put more resources and Full Time Equivalent
(FTE) positions into the petition review process. The agency
may propose user fees to fund pre-filing consultation
activities with sponsors.\3\
\3\ HRIR interview with FDA Deputy Commissioner William Schultz,
October 2, 1995.
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The Federal Food, Drug, and Cosmetic Act (FFDCA) of 1938
gave the Food and Drug Administration (FDA) authority over food
and food ingredients. The Food Additive Amendments to the FFDCA
were passed by Congress in 1958 to require FDA's pre-market
approval for the use of an additive prior to its inclusion in
food. This authority is now found in section 409 of the
FFDCA.\4\
\4\ 21 U.S.C. 348.
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An additive is defined as ``any substance the intended use
of which results or may reasonably be expected to result,
directly or indirectly, in its becoming a component or
otherwise affecting the characteristics of any food.'' This
definition covers any substance used in the production,
processing, treatment, packaging, transportation or storage of
food such as colors, packaging materials, artificial sweeteners
and fat substitutes.
Food additives are commonly used to: impart or maintain
desired consistency, improve or maintain nutritive value,
maintain palatability and wholesomeness, produce texture,
control acidity/alkalinity and enhance flavor or impart color.
Direct additives are added to food for a specific purpose, such
as a fat replacer or artificial sweetener. High profile direct
additive petitions under review at FDA include: Johnson and
Johnson's (McNeil division) SUCRALOSE artificial sweetener and
Proctor and Gamble's OLESTRA fat replacer.
Indirect additives may become part of the food in trace
amounts due to packaging, storing or other handling. The law
also requires the manufacturer to prove an additive's safety
for the ways it will be used in foods, such as for fat
replacement, fiber addition, or as a sweetener.
The statutory standard is rigorous but not absolute. An
additive is deemed safe if the sponsor proves to a ``reasonable
certainty that no harm would result from the substance under
its intended conditions of use.'' The amendments also included
the Delaney clause which stipulates that ``no food additive can
be deemed safe if it has been found to induce cancer when
ingested by man or animals.'' \5\
\5\ Pub. L. No. 85-929, 4, 72 Stat. 1785 (1958), as amended, 21
U.S.C. 348(c) (3) (A) (1982).
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Two groups of substances were exempt from the Food
Additives Amendments. They included substances sanctioned by
FDA or USDA prior to 1958, such as calcium propionate,\6\ and
substances considered generally recognized as safe (GRAS), such
as salt, sugar, spices, vitamins, etc.\7\
\6\ Section 201 (s) (4) of the FFDCA, 21 U.S.C. 321 (s) (4).
\7\ 21 CFR 182.1 (a).
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Food additive petitions must be reviewed and acted upon
``not more than 180 days after the date of filing of the
petition.'' \8\ Upon approval of a food additive petition, FDA
issues regulations including the types of foods in which an
additive can be used, the maximum amounts to be used, and how
additives must be listed on food labels. Meat and poultry
additives are reviewed by USDA and FDA.
\8\ 21 U.S.C. 348 (c) (2).
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A. THE REVIEW PROCESS
A sponsor who seeks to market a food additive must submit a
petition to FDA establishing that the substance is safe for its
intended use and that it performs its intended function. FDA
evaluates the adequacy of the petition for evaluation and the
need for scientific evaluation outside FDA's Center for Food
Safety and Applied Nutrition (CFSAN). The petition is
simultaneously reviewed by the Division of Product
Manufacturing, the Division of Health Effects Evaluation, the
Division of Molecular Biology and other CFSAN offices as
determined by CFSAN's Office of Premarket Approval at the time
of submission.
Under the National Environmental Policy Act (NEPA), FDA
must evaluate the potential environmental effects of the
substance and include this evaluation in its decision-making. A
safety determination is made, an administrative record is
compiled and a rule is drafted. The petition receives a legal
review by FDA General Counsel and a policy review by the Office
of the Commissioner before publication in the Federal Register
and then in the Code of Federal Regulations. A food additive
regulation is not a product license limited to a single sponsor
or manufacturer. Any manufacturer may market an approved food
additive under approved conditions of use.\9\
\9\ HRIR Hearings, p. 5 (testimony of Linda Suydam).
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Few, if any, food additive petitions are acted upon in the
statutorily-prescribed time period. Frequently, food additive
petitions remain in pending status, while the agency asks for
more data. At a meeting on June 16, 1995 with Subcommittee
staff, FDA Deputy Commissioner for Policy William Schultz
stated that the 180 day review period was unrealistic and that
he felt no one in industry or at the FDA thought it realistic
to expect reviews to be completed in 180 days.
B. FOOD ADDITIVE DELAYS
FDA has a backlog of 295 food additive petitions under
review, some of which have been pending since the 1970s.
Approximately 100 new food and color additive petitions are
submitted to the FDA each year.
Indirect additives comprise approximately half of all
pending petitions, and are believed by many industry sources to
be languishing due to low priority within the Center.\10\
Direct additives comprise approximately 17% of pending
petitions and may be under review for up to 10 years while
agency reviewers ascertain their safety, often with repeated
requests for additional animal studies and safety data.
\10\ Delays in the FDA's Food Additive Petition Process and GRAS
Affirmation Process: Hearings Before the Subcommittee on Human
Resources and Intergovernmental Relations of the House Committee on
Government Reform and Oversight, 104th Cong., 1st Sess. 131-132 (1995)
(``HRIR Hearings'') (statement of Jerome Heckman).
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For example, McNeil's SUCRALOSE petition was filed with FDA
in February, 1987, but has not yet been approved. It was filed
in Canada and Australia in April and June, 1987, and approved
in Canada in September, 1991. Australia's National Food
Authority announced its intention to approve SUCRALOSE subject
to a public comment period and consideration by the National
Food Standards Council (which is comprised of public health
ministers at State, Territory, and Federal levels) in December
1991. Final Australian approval was received in October,
1993.\11\
\11\ McNeil chronology document in Subcommittee files.
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C. GRAS DELAYS
In March 1972, the FDA contracted with the Federation of
American Societies of Experimental Biology (FASEB) to evaluate
the safety and health effects of over 468 food additives
considered generally recognized as safe or ``GRAS'' at the time
of the 1958 amendments. In March 1982, FASEB completed its
evaluation of 422 direct additives and 46 indirect additives.
It determined that 339 or 72% were considered GRAS with no
evidence of adverse health effects. Sixty-nine or 15% were GRAS
with additional data required if increased or new uses are
contemplated.
Twenty-one or 5% were permitted to receive an interim food
additive regulation requiring that testing be undertaken but
given GRAS status until such tests are completed and evaluated.
Five or 1% had insufficient evidence to determine if reported
adverse health effects were not deleterious. It was recommended
that safe conditions of use be established for these five
additives.
Thirty-four or 7% had inadequate data on biological studies
which precluded evaluation. An invitation to submit data was
recommended, and if none was received, there was a recommended
recision of GRAS status. A number of GRAS substances reviewed
by FASEB have yet to be acted upon by FDA.
GRAS petitions are not required by law but are voluntarily
submitted to obtain FDA concurrence that premarket approval is
not required. However, due to liability concerns, processed
foods manufacturers are increasingly unwilling to purchase GRAS
substances without an affirmation letter from FDA. Seventy-five
GRAS affirmation petitions are currently pending at FDA, the
oldest of which was filed on August 31, 1972.
On June 22, 1995, the FDA presented at the Subcommittee
hearing an administrative plan to rectify the backlog and
address delays in the food additives program. The plan
included:
reorganization of FDA's Center for Food Safety and
Applied Nutrition (CFSAN) to place petition review resources
under one central manager;
development and issuance of a ``threshold of
regulation'' approach for indirect additives that meet specific
criteria;
performance goals to review petitions within
defined time periods;
reform of the GRAS regulatory process;
additional agency resources to reduce the
inventory of pending petitions;
use of external scientific expertise to expedite
the review of pending petitions;
elimination or reduction of requirements for
environmental assessments for many petitions;
expanded programs to help petitioners submit
complete, sufficient submissions.\12\
\12\ HRIR Hearings, p. 10-11 (statement of Linda Suydam).
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III. FINDINGS
1. FDA does not meet the 180 day statutory deadline to review and make
a decision on food additive petitions.
The agency views the 180 day statutory time frame as a
goal, not a binding requirement. FDA Interim Deputy
Commissioner for Operations Linda Suydam testified that the
agency views the 180 day time frame as ``a target, and we try
to meet that target.'' \13\
\13\ HRIR Hearings, p. 26.
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The FDA does not meet the 180 day target. Data supplied by
FDA at the June 22, 1995 hearing indicate that since 1970, the
average time to approval of a direct food additive has been at
least 20 months.\14\ FDA General Counsel Margaret Jane Porter
stated that, in her view, the 180 day statutory limit was
``ridiculous.'' \15\ Chairman Shays stated at the June 22
hearing that ``the statutory deadline has been interpreted out
of existence by the FDA, and I am eager to learn how the agency
plans to restore accountability to the process for determining
the safety of food additives.'' \16\
\14\ HRIR Hearings, p. 16, FDA supplied chart.
\15\ HRIR Hearings, p. 25.
\16\ HRIR Hearings, p. 2 (statement of Chairman Christopher Shays).
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FDA testified that the establishment of performance goals
for the food additive petition review process will provide a
mechanism to fulfill the Agency's commitment to timely and
predictable decision making.\17\ However, the plan submitted by
the agency to relieve the backlog of pending petitions \18\ was
not in compliance with the statute.\19\
\17\ HRIR Hearings, p. 13 (statement of Linda Suydam).
\18\ Ibid.
\19\ HRIR Hearings, p. 25-27.
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2. As of June 22, 1995, there were 295 pending food additive petitions
(direct, indirect, and GRAS), some of which were filed in the
1970s.
The FDA provided the Subcommittee with a list of 295
pending food petitions.\20\ Sixty-six percent of pending
petitions were filed between 1990-1994, 27% between 1980-1989,
and 7% between 1971-1979.\21\
\20\ HRIR Hearings, p. 24, FDA supplied chart.
\21\ Letter of May 2, 1995 FDA response to Chairman Shays inquiry
(in subcommittee files).
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3. The lack of fixed deadlines and the increased scientific ability to
detect and measure potential hazards have resulted in a review
process that is risk-averse.
Under-funding and under-staffing of the CFSAN were cited by
FDA and academic witnesses \22\ as impediments to timely
scientific review, sound scientific judgement, and support for
new food technologies. However, the inability of CFSAN
reviewers to recognize the degree of actual risk, \23\ or no
risk, posed by low levels of materials as used in practice, as
opposed to materials which present a minimal or theoretical
hazard at much higher levels, was also identified as an
impediment to timely review of food petitions.\24\
\22\ HRIR Hearings, p. 35-37 (statement of Dr. Sanford Miller).
\23\ Ibid.
\24\ HRIR Hearings, p. 49.
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The statutory charge is to determine the safety of food
additives, applying the best science available, not an absolute
standard of zero risk. FDA regulations define safety as ``the
reasonable certainty in the minds of competent scientists that
the substance is not harmful under the intended conditions of
use. It is impossible in the present state of scientific
knowledge to establish with complete certainty the absolute
harmlessness of the use of any substance.'' \25\
\25\ 21 CFR. 170. 3(i); HRIR Hearings, p. 41 (statement of Dr.
Richard Hall).
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4. The FDA is reluctant to decline incomplete or inadequate petitions,
and consequently, allows incomplete and inadequate petitions to
remain under review at FDA for more than 180 days.
FDA stated that industry prefers a longer review time to a
refusal to file or rejection of a petition.\26\ Industry is
unwilling to push FDA for a decision on a food additive because
companies fear rejection of the petition.\27\
\26\ HRIR Hearings, p. 10 (statement of Linda Suydam); p. 23.
\27\ HRIR Hearings, p. 10 (statement of Linda Suydam); p. 105-106.
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The quality of submitted petitions is often inadequate. FDA
expressed support for an industry proposal that would assist
petitioners in developing their food additive petitions prior
to submission to the FDA.\28\ Pfizer and other food companies
have developed a proposal to use expert scientists to review
the scientific data of food additive petitions that are
submitted to FDA.
\28\ HRIR Hearings, p. 19.
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Under the proposal, as the petitions are submitted the
relevant safety sections would also be submitted to expert
panels, which would be selected and administered by an
independent, third party institution. This plan would be funded
by annual grants from ingredient suppliers and food companies
and the expert panels would be funded by an assessment fee for
each petition. Panel reports and recommendations would be
submitted by the petitioner to the FDA but FDA would retain
approval authority.\29\
\29\ HRIR Hearings, p. 163 (statement of Donald Farley).
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5. FDA has committed insufficient resources to its food additive review
responsibilities.
FDA has taken resources from the food programs, which
comprise more than 50% of the agency's responsibilities,\30\
and devoted them to drug and biologic reviews.\31\
\30\ FDA Almanac FY1994, p. 68.
\31\ HRIR Hearing, FDA Centers Personnel Chart, p. 60.
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Allocation of internal resources by FDA management
jeopardizes the food programs. In FY 1994 the total FDA budget
was $873,048,000 of which $221,648,000, or 25%, were devoted to
food regulation.\32\ However, foods represent more than 50% of
FDA's workload.
\32\ FDA Almanac FY1994, FDA's Budget Chart, p. 11.
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The CFSAN staffing levels are about the same as 10 years
ago after dropping to their lowest levels in FY1989. Comparison
with budget changes for the Centers for Drugs and Biologics
shows a 60% increase for the drug and biologics programs while
CFSAN staffing remains at the same level.\33\
\33\ HRIR Hearings, FDA Center Personnel Chart, p. 61.
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The leveling of FDA resources for foods in recent years is
in sharp contrast with the increased responsibilities CFSAN has
assumed due to new legislation in the areas of nutrition
labeling,\34\ nutrition monitoring, pesticide monitoring, and
safe transport of food. The food supply for which FDA is
responsible has grown enormously in the number of food products
and in diversity of source and processing since the FFDCA was
enacted in 1906 and the food additive amendments were enacted
in 1958.
\34\ HRIR Hearings, p. 41 (statement of Dr. Richard Hall).
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The Prescription Drug User Fee Act (PDUFA) \35\ allows user
fees to be used as a supplement to the FDA's appropriated
budget only if FDA allocates funding for drug and biologics
programs at 1992 inflation adjusted levels. FDA Interim Deputy
Commissioner for Operations Linda Suydam testified that ``as a
result (of PDUFA), the other parts of the agency's programs
have to take cuts to make up for that large program being
protected.'' \36\
\35\ 21 U.S.C. 379(h).
\36\ HRIR Hearings, p. 28.
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6. FDA does not set food additive petition review priorities
appropriately.
Seventy-five percent of food additive petitions are for
indirect additives and 25% are for direct additives.\37\
Indirect additives generally require fewer resources and less
review than direct additives.\38\ However, the FDA does not
assign greater resources to direct petitions as opposed to
indirect petitions, instead utilizing a ``first in, first out''
review system which does not devote the greatest resources to
the applications with the greatest resource requirements.
\37\ HRIR Hearings, p. 31.
\38\ HRIR Hearings, p. 139-141 (statement of Jerome Heckman).
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7. FDA's failure to expeditiously review food additive petitions has
stifled innovation and introduction of new ingredients by the
food industry.
The food industry, which is now international in nature, is
extremely adverse to taking risks in the introduction of new
products. If new technologies have to undergo long periods of
review without decision by the agency, the result is an
industry which tends to repeat past technologies rather than
developing new ones.\39\ Several companies told the
Subcommittee staff in interviews that they had abandoned
research into promising food additives because of the delays in
the petition review process. One company testified that
consideration had been given to ``abandoning our U.S. based
research.'' \40\
\39\ HRIR Hearings, p. 35-36 (statement of Dr. Sanford Miller).
\40\ HRIR Hearings, p. 162-163 (testimony of Mr. Donald Farley).
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8. A petition review process with no fixed deadlines can be manipulated
for anti-competitive purposes.
The FDA received safety objections regarding petitions
under review from anonymous sources which may have been
motivated by economic, social, or political forces.\41\
Industry representatives believe that the review process has
been manipulated to cause delays.\42\ FDA admitted that this is
a problem with the current system.\43\
\41\ HRIR Hearings, p. 40 (testimony of Dr. Richard Hall);p. 90-91;
p. 101 (statement of Dr. Wayne Callaway); see also p. 181 (statement of
Dr. Michael Jacobson)
\42\ HRIR Hearings, p. 40 (testimony of Dr. Richard Hall), p. 43
(statement of Dr. Richard Hall).
\43\ HRIR interview with Deputy Commissioner William Schultz,
October 2, 1995.
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9. FDA does not make sufficient use of independent scientific resources
for food additive petition review.
FDA cannot maintain sufficient scientific expertise in all
areas necessary for review of more complicated and
scientifically advanced petitions. Industry sources report that
FDA review of macroingredient \44\ petitions in particular now
requires an increasing reliance on nutritional and clinical
studies as opposed to traditional toxicological studies in test
animals. Therefore, FDA requires access to more human and
veterinary medical reviewers and nutritionists as opposed to
toxicologists.
\44\ ``An element of carbon, hydrogen, oxygen, or nitrogen, needed
in large amounts for plant growth and development.'' Webster's II New
Riverside University Dictionary (1988).
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Toxicology reviews of food additive petitions were listed
as a significant source of delay at FDA. Former FDA
toxicologists and industry regulatory affairs professionals
cited a lack of scientific resources and confidence in
toxicology personnel.\45\ FDA has inadequate access to top-
level expertise in toxicology, especially experienced risk
assessment personnel.\46\
\45\ HRIR Hearings, p. 41 (statement of Dr. Richard Hall).
\46\ HRIR Hearings, p. 163 (statement of Mr. Donald Farley).
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The FDA presented a plan to utilize existing contracts with
independent, third-party scientific organizations to aid the
agency's review of food additive petitions.\47\ In order to
keep up with increasing industry requirements for food additive
reviews, FDA must look outside the agency for additional
scientific review resources to supplement agency resources.\48\
\47\ HRIR Hearings, p. 12 (testimony of Linda Suydam).
\48\ HRIR Hearings, p. 49.
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IV. RECOMMENDATIONS
1. Congress should amend the Federal Food, Drug and Cosmetic Act review
period for food additive petitions, from 180 to 360 days for
the most scientifically complex reviews, and the deadline
should be strictly observed by FDA.
The 180 day time frame has been meaningless for many years
as evidenced by the list of 295 pending petitions submitted by
FDA to the Subcommittee. Food manufacturers need ``some
finality to the process of additive review . . . deadlines for
(agency) actions that are appropriate and real, and not merely
advisory.'' \49\
\49\ HRIR Hearings, p. 119 (testimony of Stuart Pape).
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Also, the 180 day statutory deadline for FDA approval/
disapproval decisions on food additive applications is no
longer sufficient for technologically advanced applications
such as food products derived through biotechnology,
macroingredients and functional foods, which are defined ``as
any modified food or food ingredient that may provide a health
benefit beyond the traditional nutrients it contains'' \50\
that provide specific health benefits.
\50\ Journal of the American Dietetic Association, ``Position of
the American Dietetic Association: Phytochemicals and functional
foods,'' p. 493, April 1995 Volume 95 Number 4.
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The food industry would support a meaningful review
deadline. Industry representatives presented a proposal for a
new food additive review system with review time frames of at
least 360 days.\51\ This proposal would, for the first time,
permit an FDA selected independent scientific review panel to
assess the safety of a food additive and make a recommendation
to FDA regarding approval or disapproval.
\51\ HRIR Hearings, p. 120 (statement of Stuart Pape).
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Under such a review process, the agency must either accept
the recommendation and issue a regulation allowing use of the
food additive or reject the recommendation and cite the reasons
for so doing. For the first time, the review process would have
a fixed deadline, after which a presumption of approval would
apply. To overcome the presumption of approval, FDA would bear
the burden of proof to rebut the third party recommendation.
If the agency did not review and make a decision on the
review panel's recommendation within statutorily prescribed
time frames, the recommendation of the scientific review panel
would become effective. The presumption of approval arising
from a favorable recommendation from the scientific review
organization will ensure that FDA meets the statutory deadline
or takes final (appealable) administrative action to extend it.
The FDA presented performance goals in testimony that
indicate that most petitions could be reviewed by the agency
within 360 days.\52\
\52\ HRIR Hearings, p. 13 (statement of Linda Suydam).
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2. The FDA should recognize that the approval of useful and safe new
products can be as important to the public health as preventing
the marketing of harmful or ineffective products. FDA's prompt
approval of new food petitions can also benefit the
environment.
The 1988 Surgeon General's Report on Nutrition and Health
stated that ``The public would benefit from increased
availability of foods and food products low in calories, total
fat, saturated fat, cholesterol, sodium and sugars.'' \53\
Physicians testified that many patients with chronic conditions
would more successfully implement long-term dietary
modifications if they had a greater variety of new foods with
lower fat, calories, sugars, and sodium.\54\ A consumer group
witness testified that reducing saturated fat intake by eight
grams a day would save as much as $24 billion a year.\55\
\53\ The Surgeon General's Report on Nutrition and Health, 1988,
U.S. Department of Health and Human Services, p. 19.
\54\ HRIR Hearings, p. 99-100 (statement of Dr. C. Wayne Callaway);
p. 102 (testimony of Dr. Michael Davidson).
\55\ HRIR Hearings, p. 182 (statement of Dr. Michael Jacobson).
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The FDA should implement Recommendation 1.4 of the Advisory
Committee on the Food and Drug Administration, which states
``FDA must recognize the approval of useful and safe new
products can be as important to the public health as preventing
the marketing of harmful or ineffective products. Specifically,
the FDA should develop a flexible range of regulatory pathways,
all of which uphold current standards of safety and efficacy,
but which reflect the fact that not all drugs, devices and
foods are alike.'' \56\
\56\ Final Report of the Advisory Committee on the Food and Drug
Administration, U.S. Department of Health and Human Services, May 1991,
p. 14.; HRIR Hearings, p. 53 (testimony of Dr. Stephen Ziller).
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FDA's prompt approval of indirect food additives for use in
new and improved food packaging can also have significant
environmental benefits. The food industry is a primary consumer
of packaging materials. Improvements in source reduction and
recycling of materials can result in immediate environmental
benefits.\57\
\57\ HRIR Hearings, p. 92-93 (testimony of Dr. D. Stephen
Saunders).
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3. The FDA should eliminate the backlog of food petitions within one
year by reallocating the necessary resources to the food
petition review program.
After the HRIR investigation into the backlog of food
additive petitions began, FDA informed the Subcommittee staff
that twenty-five individuals have been reassigned within CFSAN
to work on food petitions and two toxicologists from the
National Center for Toxicological Research (NCTR) have been
devoted to CFSAN food petition toxicology reviews. FDA will
hire immediate contract help to focus on chemical,
toxicological and environmental reviews of low priority
petitions.\58\ Furthermore, FDA testified that $7 million was
added to the indirect additive review program to eliminate the
backlog.\59\
\58\ HRIR Interview with FDA Deputy Commissioner for Policy William
Schultz; October 2, 1995.
\59\ HRIR Hearings, p. 22 (testimony of Linda Suydam).
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4. The FDA should utilize outside expertise in its evaluation of food
additive petitions in order to reach prompt and responsible
decisions on the safety of these products. The FDA should
retain responsibility for petition approvals.
Utilization of outside scientific expertise will provide
FDA with access to a wider range of expertise and extend the
agency's scientific resources. FDA proposed to award a contract
for independent third-party scientific review of some indirect
additive petitions as part of its administrative reform
proposal.\60\
\60\ HRIR Hearings, p. 12 (statement of Linda Suydam).
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Food scientists and industry witnesses proposed a system
whereby an independent third party scientific review
organization may review a petition and find an additive safe
for its intended use. FDA must concur with the scientific
review or the agency may refuse to do so only on the basis of
explicitly stated, substantially supported countervailing
considerations. If FDA does not issue a regulation or report
defending an opposing view within a prescribed time, then
presumptive approval would become final.\61\ The FDA must
select the appropriate extramural review group and it must set
the criteria for selection of members of the review panels of
these groups to avoid the appearance of a conflict of interest
and lack of public confidence in the process.\62\
\61\ HRIR Hearings, p. 36 (statement of Dr. Sanford Miller)
\62\ Ibid.
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The agency should be encouraged to sort out those issues
which the agency itself must resolve as opposed to those which
may pose lesser risk and which may be scientifically reviewed
by external groups under the agency's authority. Industry
witnesses support retention of final decision making by the
FDA.\63\ Consumer groups expressed support for utilization of
third-party toxicology reviews with retention of final approval
authority by FDA.\64\
\63\ HRIR Hearings, p. 40, 44 (statement of Dr. Richard Hall); p.
119 (testimony of Stuart Pape).
\64\ HRIR Hearings, p. 175 (testimony of Dr. Michael Jacobson).
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5. The relevance of the Delaney clause should be studied in view of
modern scientific standards so that better distinctions can be
made between nominal hazards and actual risks.
The Delaney clause stipulates that no food additive can be
deemed safe if it has been found to induce cancer when ingested
by man or animals. The Delaney clause was enacted at a time
when it was not possible to detect the presence of chemicals at
ratios of as little as .02 parts per trillion. This scientific
advancement may require implementation of more subtle risk
based approaches. In addition, some substances at minimal
levels present no risk to humans through consumption. The
agency should establish a level of acceptable risk for food
additives, below which there is no hazard to humans through
consumption under normal or intended use.\65\
\65\ HRIR Hearings, p. 50.
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6. The FDA should amend the review process to prohibit anonymous
submissions of data or comments.
Companies have utilized anonymous submissions of data to
delay review of competitors' products.\66\ Manipulation of the
food additive review process for anti-competitive purposes is
inconsistent with the purposes of pre-market review. FDA should
prohibit the consideration of information from anonymous
sources.
\66\ HRIR Hearings, p. 40 (testimony of Dr. Richard Hall);p. 90-91;
p. 101 (statement of Dr. Wayne Callaway); see also p. 181 (statement of
Dr. Michael Jacobson).
ADDITIONAL VIEWS OF HON. DAVID M. McINTOSH AND HON. MARK E. SOUDER
The Committee's report offers a candid assessment of the
problems that plague the FDA's food approval process. With
nearly 300 food additive petitions pending with the FDA (some
that were filed in the 1970's), it is obvious that the system
in place at the FDA today is not capable of meeting the current
statutory mandate that all food additive applications be
approved or declined within 180 days of submission. The
Committee's recommendations are sound ones that should be well
accepted by the food industry, consumer groups, and the FDA.
Unfortunately, I am concerned that the enforcement mechanisms
for the Committee's recommendations are inadequate.
Currently, the FDA's delay in approving food additives is
caused by inertia within the agency. While that inertia can be
somewhat alleviated through instructions to do better, I am
convinced that it cannot be eliminated without a significant
enforcement hammer. I am particularly concerned that the
recommendations include a relaxation of the statutory deadline
for a decision on a food additive from 180 to 360 days.
While relaxing the statutory deadline makes some sense, it
also makes sense to transform it into a meaningful one. If the
time frames in the Government Reform and Oversight Report were
expected to be 360 days, then after a brief period--90 days
perhaps--the statute should provide FDA with three options: (1)
issue a regulation approving the use of the additive, (2)
disapprove the use of the additive, but only if FDA can
demonstrate that an additive has not been found to be safe, or
(3) if FDA fails to do either, the additive is deemed to be
approved. In this way, FDA is provided an incentive to engage
in a real cost/benefit analysis in the allocation of its
resources. I am convinced that unless hammers such as this one
are incorporated into the regulatory schemes we have developed,
we are destined to see agencies fail to meet statutory
deadlines and justify their failures with claims of too much
work and too few resources.
David M. McIntosh.
Mark E. Souder.
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