95th Congress COMMITTEE PRINT CIMrE 2d Session PRINT 9--47
TEXT AND SUMMARY OF H.R. 10358
THE "FOOD SAFETY AND NUTRITION AMENDMENTS
PREPARED BY THE STAFF
FOR TME USE OF THE
COMMITTEE ON INTERSTATE AND
U.S. HOUSE OF REPRESENTATIVES
HEALTH AND THE ENVIRONMENT
MARCH 197 "
U.S. GOVERNMENT PRINTIV/,oI e. 20-954 WASHINGTON: 1978. I
COMMITTEE ON INTERSTATE AND FO REIGN COMMERCE
HARLEY 0. STAGGERS, West Virginia, Chairman JOHN E. MOSS, California SAMUEL L. DEVINE, Ohio
JOHN D. DINGELL, Michigan JAMES T. BROYHILL, North Carolina
PAUL G. ROGERS, Florida TIM LEE CARTER, Kentucky
LIONEL VAN DEERLIN, California CLARENCE J. BROWN, Ohio
FRED B. ROONEY, Pennsylvania JOE SKUBITZ, Kansas
JOHN M. MURPHY, New York JAMES M. COLLINS, Texas
DAVID E. SATTERFIELD III, Virginia LOUIS FREY, JR., Florida
BOB ECKHARDT, Texas NORMAN F. LENT, New York
RICHARDSON PREYER, North Carolina EDWARD R. MADIGAN, Illinois
CHARLES J. CARNEY, Ohio CARLOS J. MOORHEAD, California
RALPH H. METCALFE, Illinois MATTHEW J. RINALDO, New Jersey
JAMES H. SCHEUER, New York W. HENSON MOORE, Louisiana
RICHARD L. OTTINGER, New York DAVE STOCKMAN, Michigan
HENRY A. WAXMAN, California MARC L. MARKS, Pennsylvania
ROBERT (BOB) KRUEGER, Texas TIMOTHY E. WIRTH, Colorado PHILIP R. SHARP, Indiana JAMES 3. FLORIO, New Jersey ANTHONY TOBY MOFFETT, Connecticut JIM SANTINI, Nevada ANDREW MA Gf RE, New Jersey MARTY RUSSO, Illinois EDWARD 1. MARKEY, Massachusetts THOMAS A. LUKEN, Ohio DOUG WALGREN, Pennsylvania BOB GAMMAGE, Texas ALBERT GORE, J., Tennessee BARBARA A. MIKULSKI, Maryland
W. E. WnLLAMSON, Chief Clerk and Staff Director KENNETH J. PAINTER, First Assistant Clerk ELEANOR A. DINKINS, Assistant Clerk WILLIAM L. BURNS, Printing Editor
ELIZABETH HARRISON CHRISTOPHER E. DUNNE
JEFFREY H. SCHWARTZ WILLIAM M. KITZMILLER
BRIAN R. MoiR MARK 3. RAABE
KAREN F. NELSON THOMAS M. RYAN
Ross D. Ai JAMES S. COWEN
H. THOMAS GREENE, Associate Minority Counsel
SUBCOMMITTEE ON HEALTH AND THE ENVIRONMENT
PAUL G. ROGERS, Florida, Chairman DAVID E. SATTERFIELD III, Virginia TIM LEE CARTER, Kentucky
RICHARDSON PREYER, North Carolina JAMES T. BROYHILL, North Carolina
JAMES H. SCHEUER, New York EDWARD R. MADIGAN, Illinois
HENRY A. WAXMAN, Californmia JOE SKUBITZ, Kansas
TAMES J. FLORIO, New Jersey SAMUEL L. DEVINE, Ohio (Ex Officio)
ANDREW MAGUIRE, New Jersey EDWARD J. MARKEY, Massachusetts RICHARD L. OTTINGER, New York DOUG WALGREN, Pennsylvania HARLEY 0. STAGGERS, West Virginia (Ex Officio)
STEPHAN E. LAWTON, Counsel ROBERT W. MAHER, Director of Research and Planning Jo ANNE GLISSON, Senior Staff Associate DONALD W. DALRYMPLE, Assistant Counsel STEPHEN J. CONNOLLY, Senior Staff Associate BURKE ZIMMERMAN, Research Associate ROBERT M. Crane, Senior Staff Associate WILLIAM V. CORR, Assistant Counsel F.NCES DE PEYSTER, Minority Staff Associate
STS~siol H. R. 10358
IN THE IIOISE OF REPRESENTATIVES
DECEMBE 15, 1977
Mr. Rozr s (for himself and Mr. CARTER) introduce, the following bill; which
was referred to the Committee on Interstate and Foreign Commerce
To amend the Federal Food, Drug, and Cosmetic Act to revise
and strengthen the authority of the Secretary of Health, Education, and Welfare under that Act with respect to the distribution and labeling of food, and for other purposes. 1 Be it enacted by the Senate ad House of Representa2 ties of the United States of America in Congress assembled,
3 SHORT TITLE; REFERENCE TO ACT; AND TABLE OF
5 SECTION 1. (a) This Act may be cited as the "Food
6 Safety and Nutrition Amendments of 1978".
7 (b) Whenever in this Act an amendment is expressed in
8 terms of an amendment to a section or other provision, the
reference shall be considered to be made to a section or other
2 provision of the Federal Food, Drug, and Cosmetic Act.
TABLE OF CONTENTS Sec. 1. Short title; reference to Act; and table of contents..
Sec.r 2. Notification.
Sec. 3. Food coding.
See. 4. Food distribution records.
Sec. 5. Registration of food processors.
Sec. 6. Preemption.
See. 7. Administrative detention.
Sec. 8. Inspections and confidentiality.
Sec. 9. Nutrition information anid other labeling rcquiieinents..
Sec. 10. Import notice Sec. 11. Presumption.
See. 12. Definitions.
Sec. 13. Margarine.
Sec 14. Alcoholic beverages.
4 SEC. 2. (a) Chapter IV is amended by adding after sec-,
5 tion 411 the following pew- section:
7 "SEe, 412. (a) Whenever a food processor8 "(1) acquires information indicating- that any.. food 9 which lie has processed and which has left his control 10. may be adulterated (within the meaning of section
11 402 (a) -or 402 (c)) he shall immediately. notify the.
12 Secretary, in such form and mariner as may be prescribed
13 by the Secretary, 'of such information; or
14 (2) institutes a recall of food which he has
15 processed and which has left an establishment subject to
16 his control and institutes such recall because he has reason
17 .to believe the food may be adulterated or misbranded,'he
1 shall immediately notify the Secretary, in such form and
2 manner as may be prescribed by the Secretary, of such
4 "(b) Information contained exclusively in a notification
5 filed by any person with the Secretary pursuant to sulbsecton 6 (a) may not be introduced as evidence in any proceeding 7 against such person under section 303 for a violation of
8 section 301.".
9 (b) Section 301 is amended by adding after paragraph
10 (r) the following new paragraph: 11 (s) The failure to make any'notification required by
12 section 412.".
13 FOOD CODING
14 SEC. 3. (a) Chapter IV is amended by adding aftei
15 section 412 (added by section 2 (a) of this Act) tho follow16 ing new section:
17 "FOOD CODING SYSTEM
18 "SEC. 413. (a) (1) Except as provided in paragraph
19 (2), each food processor of food shall in accordance with 20 regulations promulgated under subsection (c) 21 "(A) establish and implement a food coding system
22 to effect and monitor recalls of such food, and
23 (B) notify the Secretary of the establishment of
24 such system and of any substantive revisions in it.
25 "(2) (A) The requirements of paragraph (1) do not
I apply to a food processor to the extent that such food proces2 .or processes agricultural commodities which are sold at re3 tail in a raw, unpeeled form.
4 "(B) The Secretary may by regulation exempt any
5 food processor or class of food processors from the require6 ments of paragraph (1) if the Secretary determines that 7 comparable requirements are applicable to such processor or s class under a Federal law other than this Act.
9 "(3) If the Secretary determines that a food coding
10 system identified in a notice submitted in accordance with 1i this subsection is inadequate to effect and monitor a recall
-12 of the food with respect to wNhich the system was estab13 wished, the Secretary shall notify the food procelssor who 4 submitted such notice of such determination, provide him 15 with a written statement of the reasons for such deternil16 nation, provide, upon request, technical assistance to revise 17 such system to make it adequate to effect and monitor a 18 recall of such food, and prescribe the time within which .19 such food processor shall submit a notice of the revised 20 system.
21 "(b) (1) Except as provided under paragraph (2),
22 a food coding system required to be established by subsec23 tion (a) (1) (A) shall consist of symbols (designated by 24 the person establishing the system) to identify the following 25 information:
1 (A) The name of the manufacturer and, if differ2 ext, the packer of the food contained in the packages
3 or other containers to be marked with such symbols.
4. "(B) The facility at which such food was rnanu5 factured or packed if such food is manufactured or
6 packed at more than one facility.
7 (C) The name of the food.
8 "(D) The lot or batch number, if any, of the food.
9 "(E) The date on which the food was packed.
10 (2) The Secretary may, by regulation, authorize a
1.1 food coding system for a particular food or class of food not 12 to include a symbol for one or more of the items of infor13 nation otherwise required to be identified by such system 14 under paragraph (1) if the Secretary det(rimines that be15 cause of the nature of sbch food oi class, the volume of such 16 food which is sold, or any other factor, the identification of 17 such information is not necessary to effect or monitor a re18 call of such food or class of food. 19 "(c) (1) The Secretary shall promulgate regulations20 (A) to define the food processors or classes of
21 food processors subject to the requirements of subsection
23 (B) prescribing the form of the notice required to
24 be submitted under subsection (a) (1) (B) and the food
25 coding information to be included in such notice,
1 (C) prescribing the packages or other containers
2 which are to be marked with the symbols of food coding
3 systems established under subsection (a) (1) (A) and
4 the manner in which such packages or other containers
5 are to be so marked, and
G (D) prescribing such other ma tters as may be re7 quired for the implementation of the requirements of
8 this section.
9 Such regulations shall provide that if informat;ou rcqttired 10 to be identified by any symbol of a food coding system is 11 otherwise on a package or other container, such package or 12 other container shall not be required to be marked with sach 13 symbol.
14 "(2) Regulations first promulgated under paragraph
.15 (1) shall take effect as prescribed by the Secretary but 16 not sooner than one hundred and eight3 days after the date 17 of such promulgation. Within ninety days of the effective 18 date of the first regulations promulgated under paragraph 19 (1), each food processor who is engaged in the processing 20 of food shall, as required by such regulations, submit the 21 notice required by subsection (a) (1) (B). Such regula22 tions shall apply with respect to packages or other con23 tainers in which food is packed after one hundred and eighty 24 days after such effective date.". 25 (b) (1) Section 403 is amended by adding after para26 graph (n) the following new paragraph:
I (o) If in a package or otber container,. unless -the
2 package or other container is marked in accordance. with
3 section 413.".
4 (2) Section #301 is amended by adding after para5graph (s) (added by section 2. (b) of this Act) the fol46 lowing- new paragraph:
7 "(t) The failure to submit a notice in accordance within
8 section 413 or the failure to revise a food coding system in
9 accordance with the requirements of that section.". 10 FOOD DISTRIBUTION RECORDS
11 SEC. 4. (a) Chapter IV is amended by adding after
12 section 4130 (added by section 'a (a) of this Act) the fol13 lowing new section:
14 "FOOD DISTRIBUTION RECORDS
15 "SEC. 414. (a) Except as provided in subsection (b),
16 each food processor shall17 "(1) make and retain such records respecting the 18- distribution of food through any establishment owned or
19 operated by such processor for the processing of food as
20 may -be necessary to effect and monitor recalls of such
21 food, and
22 "(2) make such records available to the Secretary
23 (or to a duly authorized representative of the.Secretary)
21 for examination and copying on or off the premises of
253 such processor,
1 "(b) The Secretary ilnay by regulation exempt any 2 food processor or class of food processors from the require3 ments of subsection (a) if the Secretary determines that the I application of such requirements to such processor or class is
5 not necessary to effect and monitor recalls of food.
6 "(c) The Secretary shall promulgate regulations pre7 scribing the records required to be made and retained tader 8 subsection (a), the form and manner in which such records 9 shall be made and retained, and such other requirements as o10 may be necessary for the implementation of such subsection. 1i Such regulations shall take effect on such date as the Secre12 tary prescribes but not sooner than one hundred and eighty 13 days after the date of their pn ,g ratoa.I. anid they shall 14 apply with respect to distrib)utiton< of food m(dc after their 15 effective date.".
16 (b) Section 301 (e) is amended (1) by striking out
17 "section 703" and inserting in lieu thereoi "section 413 or 18 703", and (2) by striking out 'section 505" and inserting 19 in lieun thereof "section 413, 505". 20 REGISTRATION OF FOOD PROCESSORS
21 SEC. 5. (a) Chapter IV is amended by adding after
22 section 413 (added by section 4 (a) ) the following new 23 section:
1 "REGISTRATION OF FOOD PROCESSORS
2 "SEC. 415 (a) (1) Each food proecuer (inluding
3 each food processor located outside the Tdited S es who 4 processes food for export to the unitedd State:) -hall register
5 with the SecretaryG (A) such person's name,
7 (B) such person's principal place of business,
8 (C) the location of each establishment owned or
9 operated by the processor and in which food is processed,
10 "(D) the foods or (if authorized by the Secretary)
11 classes of foods processed in each such e tablishment,
12 (E) a description of the categories of processing
13 activities conducted in each such establishment, and
14 (F) if the processing activities are not continuous,
15 the periods of time during which such activities are
17 "(2) Before first engaging in the processing of food a
18 person shall register with the Secretary the information 19 required by paragraph (1). 20 "(3) Any person who has registered with the Secre21 tary pursuant to paragraph (1) or (2) and who discon22 tinues (on other than a temporary basis) a food processing 23 activity identified in such registration or otherwise makes a
substantive change in such activity or in a -food or establishSment associated with it shall promptly notify the Secretary of
3 such change.
(b) The Secretary shall promulgate regulations pre5scribing the form of the registration and notice required by subsection (a), the manner and time in which such regisStration and notice shall be made, and such other matters as smay be required for the implementation of this section. Such regulations shall take effect as prescribed by the Secretary :L but not sooner than one hundred and eighty days after the
~~date of their promulgation.
12 "(c) The Secretary may, by regulation, exempt any 13 food processor from the requirements of subsection (a) if 14 the Secretary determines that the application of such require15 ments to such processor is not necessary for the protection 16 of the public health,".
17 (b) (1) Section 403 is amended by adding after para18 graph (o) (added by section 3a (b)) the following new 19 paragraph:
20 (p) If it was processed in an establishment not regis21 tered in accordance with section 415 or if it was not de22scribed in a registration required by such section.".
2"3 (2) Section 301 is amended by adding after paragraph.
24 (t) (added by section 3to (b) ) the following new paragraph:
1 "(u) The failure to register in accordance with section
2 415 or the failure to provide a notice required by such sec8 tion.".
4 (3) Section 801 is amended by adding at the end the
6 (e). The Secretary of the Treasury shall refuse adniis7 slon of any food processed in an establishment not registered
8 in accordance with section 415.".
10 SEC. 6. Chapter IV is amended by adding ,ifter section
:11 415 (added by section 4 of this Act) the following new :12 section:
13 "STATE AND LOCAL FOOD LABELING REQuIRzEmENBTS
-14 "SEC. 416. (a) Except as provided in subsection (b),
15 no State or political subdivision of a State may establish cr 16 continue in effect a labeling requirement applicable to any 37 food which is different from or in addition to any labclinr 18 requirement applicable to such food under section 403. 19 "(b) 'Upon' application of a State or a political sub20 division thereof, the Secretary may, by regulation after no21 tice and opportunity for an oral hearing, exempt from 22 subsection (a), under such conditions as may be prescribed 23 in such regulation, a labeling requirement of such State or 24 political subdivision if the Secretary determines that the
1 reqlireulenit is required by compelling, local conditions and 2 comliance with it would not cause a food to be in violation
3 of a requirement under section 403.".
4 ADMINISTRATIVE DETENTION
5 SEC. 7. (a) Section 304 is amended by adding at the
C end the following new subsection:
7 "(h) (1) If during an inspection conducted under secS tion 704 of a facility or a vehicle, a food which the officer or 9 employee making the inspection has reason to believe is 10 adulterated or misbranded is found in such facility or vehicle, 11 such officer or employee may order the food detained (in 12 accordance with regulations prescribed by the Secretary) for 13 a reasonable period which may not exceed twenty days un14 less the Secretary determines that a period of detention great15 er than twenty days is required to institute an action under 16 subsection (a) or section 302, in which case he may author17 ize a detention period of not to exceed thirty days. Regula18 tions of the Secretary prescribed under this paragraph shall 19 require that before food may be ordered detained under this 20 paragraph the Secretary or an officer or employee designated 21 by the Secretary approve such order. A detention order 22 under this paragraph may require the labeling or marking of 23 food during the period of its detention for the purpose of 24 identifying the food as detained. Any person who would be 2a entitled to claim food if it was seized under subsection (a)
1 may appeal to the Secretary a detention of such food under 2 this paragraph. Within five days of the date an appeal of a 3 detention is filed with the Secretary (or within such other 4 period as may be mutually agreed upon by the Secretary and 5 the person bringing the appeal), the Secretary shall after 6 affording opportunity for an informal hearing by order con7 firm or revoke the detention.
8 "(2) (A) Except as authorized by subparagraph (B),
9 food subject to a detention order issued under paragraph 10 (1) shall not be moved by any person from the place at 11. which it is ordered detained until12 "(i) released by the Secretary, or
13 (ii) the expiration of the detention period appli14 cable to such order,
15 -whichever occurs first.
16 "(B) Food subject to a detention order under para17 graph (1) may be moved in accordance with regulations 18 prescribed by the Secretary.". 19 (b) Section 301 is amended by adding after paragraph
20 (u) (added by section 4 (b) (2)) the followivng wm para21 graph:
22 "(v) The movement of food in violation of an order
23 under section 304 (h) or the removal or alteration of any 24 mark or label required by the order to identify the food 25 as detained.".
"( INSPECTIONS AND CONFIDENTIALITY
2 SEC. 8. (a) Section 704 (a) is amended by adding
3 at the end the following: "An officer or employee making 4 an inspection under this subsection for purposes of enforcing 5 the requirements of this Act applicable to food shall be 6 permitted, at all reasonable times to have access to and to 7 copy and verify any records bearing on whether food manu8 factured, processed, packed, or held in the facility inspected
9 is adulterated or misbranded.". 10 (b) Section 708 is amended by adding at the end the
11 following: "The Secretary shall establish procedures to as12 sure the confidentiality of records which are made available 13 for inspection under section 704 and which relate to infor34- mation which is exempt from disclosure pursuant to sub15 section (a) of section 5052 of title 5, United States Code, 16 b)y reason of subsection (b) (4) of such section.".
17 NUTRITION INFOR NATION ANDr OTHER LABELING
19 SEC. 9. (a) (1) Section 403 is amended by adding at
20 the end the following:
21 (o) (1) If a perishable or semniperishable food in
22 package form, unless the package is labeled to show the sell 23 date for such food.
24 (2) For purposes of subparagraph (1) :
25 "(A) The term 'perishable or semiperishable food'
1 means any food (other than a raw agricultural comn2 modity) which the Secretary determines has a high
3 risk of any of the following as it ages:
4 (i) Decay or deterioration.
5 (ii) Significant loss of nutri'ional value or
7 (B) The term 'sell date' means the last date on
8 which a perishable or semiperishable food can be sold
9 for consumption without a high ;isk o' >o:ule or
10 significant loss of nutritional value or ,a-rtab:lity if
11 stored by the consumer after that date for the period
12 which a consumer can reasonably be expected to store
13 such food.
14 "(3) The Secretary shall promulgatc regulations pre15 scribiig the manner in which packages are to be labeled 16 under subparagraph (1). Such regulations shall require that 17 such labeling be done in such form and manner that the 18 consumer may readily identify and understand the signifi19 cance of the labeling without reference to any decoding in20 formation. Such regulations shall take effect as prescribed 21 by the Secretary but not sooner than one hundred and 22 eighty days after the date of their promulgation.". 23 (2) The requirement of section 403 (0) of ie Federal
24 Food, Drug, and Cosmetic Act, shall apply with respect 25 to food which i- packaged in the form in which it is to be
1 sold to consumers after the effective date of the regulations 2 of the Secretary of Health, Education, and Welfare, pronaul3 gated tinder such section.
4 (b) (1) Section 401 is amended by striking out the
5 fourth sentence thereof.
6 (2) Section 403 (g) is amended to read as follows:
7 "(g) If it purports to be or is represented as a food for
8 xhich a definic;on and standard of identity have been pre9 scribed by regulations as provided by section 401, unless
-10 (1) it conforms to such definition and standard; and (2) 11 its label bears the name of the food specified in such defini12 tion and standard.".
13 (3) (A) Sec'on 403 (i) is amended to read as follows:
"14 "(i) Unless 'Ls label bears15 "(1) in the case of a food which is not subject to
16 paragraph (g) of this section, the common or usual
17 name (if any) of the food; and
18 "(2) ip case it is fabricated from two or more in19 gredients20 69 (A) ihc common or usual name of each such
21 ingredient in the order of its predominance, except
22 that any ingredient which is a spice or flavoring
93 and which is not sold as such shall be designated as
24 spice or flavoring, as the case may be, unless the
25 Secretary requires by regulation that the common
1 or usual name of such spice or flavoring be oi the
2 label for the purpose of providing important health
,0 information to consumers,
4 "(B) a declaration of the percentage of any
5 specified ingredient (other than a spice or flavorG ing) if the Secretary determines by regulation that
7 such ingredient has a significant bearing on the
8 quality, nutrition, acceptability, or cost of such
9 food, and
10 "(C) any symbol required by the Secietary to
11 signify the absence of an artificial flavor or color.
I12 To the extent that compliance with the requirements of 0j subparagraph (2) is impracticable or would result in decep14 tion or unfair competition, the Secretary shall by regulation 15 prescribe exemptions from such requirements.". 16 (B) The second sentence of section 403 (k) is repealed.
17 (4) Section 403 is amended by adding after paragraph
18 (o) (added by subsection (a) (1) ) the following new para19 graph:
20 "(p) If a food for human consumption and in package
21 form, unless its label bears such nutrition informationrelating 22 to the food as the Secretary by regulation prescribes to pro23 vide important health information to consumers.". 24 (5) The amendments made by this subsection shall
25 apply with respect to food which is introduced or delivered
1 for introduction into interstate commerce after one year after
2 the date of the enactment of this Act.
3 (c) If the Secretary of Health, Education, and Welfare
4 requires under section 403 (p) of the Federal Food, Drug, 5 and Cosmetic Act that the label of a food bear nutrition
6 information, the Secretary shall7 (1) notify the Federal Trade Commission of such
8 requirement, and
9 (2) recommend to the Commission which (if any)
10 of such information should be required by the Commis11 sion under the Federal Trade Commission Act to be
12 included in the advertising of such food.
13 The Secretary shall report annually to the Committee on 14 Inte) state and Foreign Commerce of the United States House 15 of Representatives and the Committee on Human Resources 16 of the Senate on any recommendation made under paragraph 17 (2).
i8 IMPORT NOTICE
19 SEc. 10. Section 801 is amended by adding after sub20 section (c) (added by section 4(b) (3) of this Act) the 21 following new subsection:
22 (f) (1) Ti Secretary of the Treasury shall refuse
23 admission of any food for wbich an import notice required
1 by paragraph (2) has not been filed with the Secretary of
2 Health, Education, uand Welfare.
3 "(2) Any person who proposes to import food into
4 the United States for commercial purposes shall file with 5 the Secretary of hIealth, Education, and Welfare an.*im6 port notice7 "(A) identifying the food proposed to be imported,
S the food processor of such food, and the registratio.
9 number assigned the food processor under section 415,
1.0 "(B) containing such other information respecting
11 such food as the Secretary may by regulation require
.12 for the protection of the public health, and
13 "(C) containing assurances satisfactory to the
14 Secretary that any requirements prescribed under sec15 tion 402 (a) (4) and applicable to such food have been
16 complied with.
17 "(3)* The Secretary shall promulgate regulations pre18 scribing the form and content of the notice required by 19 paragraph (2) and the time and manner in which such 20 notice 'shall be submitted to the Secretary' Such regula21 lions shall take effect on such date as the Secretary shall 22 prescribe but not sooner than one hundred and eighty days .23 after the date of their promulgation, and they shall apply
1 with respect to the importation of food after their effective
4 SEc. 11. Section 709 is amended by inserting "or food"
5 after "a device".
I SEc. 12. Section 201 is amended by adding at the end
8 the following:
9 "(z) (1) The term 'food processor' means any person
.10 who owns or operates any establishment in which food is 11 manufactured, prepared, treated, packed, labeled, stored, or 12 otherwise handled or through which food is imiported for 13 commercial purposes, except that the proce-sing in an estab14 lishment of food for retail sale in such esta ishnent does 15 not make the owner or operator of such establishment a food 16 processor for purposes of this Act. 17 (2) The term 'process' when used to describe an
18 activity involving food includes the manufacturing, import19 ing, preparing, treating, labeling, storing, and other handling 20 of food.".
22 SEc. 13. Sections 301 (m), 402 (e), and 407 are.
1 ALCOTTOLIC REVELtAcES
2 SEC. 14. Section 201 (f) (1) is aiiieiidcd to r'(Td a
8 follows: "( ) articles used (A) for food for liil .or other
4 animals, alnd (B) as drinkl, for mali or otl.er aiihnal inellidig
() distilled spirits, wines, and malt bcerags,".
SUMMARY OF H.R. 10358, THE FOOD SAFETY AND NUTRITION, AMENDMENTS OF 1978
Section 2 of the bill requires food processors to notify the Secretary of Health, Education, and Welfare whenever they acquire information indicating that any food which they process, and which has left their control, may be adulterated within the meaning of section 402 (a) or (c) of the Federal Food, Drug and Cosmetic Act (hereinafter referred to as "the Act"). It also requires food processors to notify the Secretary of any recalls of food they have distributed if they have reason to believe that the food is adulterated or misbranded. It provides sanctions for failure to make these required notifications.
These provisions of the bill are intended to obligate food processors to keep the Secretary apprised of their actions in detecting and recalling adulterated or misbranded foods.
2. FOOD CODING
Section 3 of the bill requires food processors to establish food coding systems to effect and monitor recalls of adulterated or misbranded foods. To the extent that food processors pack agricultural commodities sold at retail in a raw, unpeeled form, they aie exempted from this requirement. Section 3 also requires food processors to submit notices of their coding systems to the Secretary and to place codes of essential information on food packages or containers. It authorizes the Secretary, to exempt food processors from the requirements respecting the establishment of food coding systems and the coding of information on packages and containers if he determines that the identification of such information is not necessary to effect or monitor a recall. It provides sanctions for failure to place codes on food containers or packages, for failure to submit coding system notices to the Secretary, and for failure to revise a food coding system which the Secretary determines is inadequate to effect and monitor recalls of the food to which the food coding system applies.
The food coding provisions of the bill require food processors to develop their own coding systems using symbols which specifically identify the name of the manufacturer and packer of the food, the facility at which the food is manufactured or packed, the name of the food, its lot or batch number, and the date it was packed.
3. FOOD DISTRIBUTION RECORDS
Section 4 of the bill requires food processors to make and retain food distribution records and to make them available for examination and copying by the Secretary to enable the Secretary to effect and monitor re alls of adulterated and misbranded foods. It provides sanctions for failure to make and retain such records and to make them available for examination and copying by the Secretary.
4. REGISTRATION OF FOOD PROCESSORS
Section 5 of the bill requires domestic food processors and foreign food processors who export food to the United States, to register with the Secretary. It requires registrations to include the name of the registrant, his principal place of business, the location of each food processing establishment owned or operated by him, the foods or classes of foods processed in each establishment, a description of the categories of processing activities conducted in each establishment, and the periods of time when processing takes place if it is not continuous. It requires the updating of registrations as changes occur respecting the information required to be provided. It authorizes the Secretary to exempt a food processor from the registration requirements if he determines that the application of these requirements to the processor is not necessary for the protection of the public health. It provides sanctions for failure to register.
In 1972 the General Accounting Office estimated there were approximately 80,000 food processing establishments in the United States. Although no figures were available as to the total number of foreign food processors who export food into the United States, a Food and Drug Administration study in 1972 estimated that the United States impq ted food from 150 countries and that 80 percent of these imports originated in 26 countries. In view of the vast number of food processors and different types of food processing operations, it is extremely difficult for the Secretary to have timely access to current information on the identity and location of food processors, the classes of food processed by each processor, and the types of processing utilized by each processor.
5. PREEMPTION OF LABELING REQUIREMENTS
Section 6 of the bill provides for preemption of State and local food labeling requirements which are different from, or in addition to, food labeling requirements under the Act. It provides that the Secretary may, by regulation and after notice and.opportunity for an oral hearing, exempt a State. or local labeling requirement from beime. preempted by a Federal requirement if he determines that it is required by compelling local conditions and compliance with it will not cause the food to be in violation of the food labeling requirements under the act.
6. ADMINISTRATIVE DETENTION
Section 7 of the bill authorizes the detention of a food by the Secretary for a period not to exceed 20 days if the Secretary as reason to believe that it is adulterated or misbranded. If the Secretary deter-
nes, that a longer period of time is necessary to institute a seizim, action against a food, the Secretary may extend the detention period for that food for not more than 10 days. The bi)l also provides procedures for appeals and informal hearings respecting detentions of food. It provides sanctions for the unauthorized movement of food in violation of a detention order and for the removal or alteration of any mark or label required by a detention order to identify the detained food.
7. INSPECTIONS AND CONFIDENTIALITY
Section 8 of the bill requires the owner, operator, or agent in charge of a food processing facility to permit access to such facility by an officer or employee- of the Department of Health, Education, and Welfare to copy and verify records bearing upon whether food manufactured, processed, packed, or held in the facility is adulterated or misbranded. It also requires the Secretary to establish procedures to assure the confidentiality of records which are made available for inspection and which are trade secrets exempted from disclosure under the Freedom of Information Act. It provides sanctions for refusal to permit entry or inspection in a facility for copying or verification of records bearing upon adulteration or misbrandincr.
8. NUTRITIONAL INFORMATION AND OTHER LABELING REQUIREMENTS
Section 9 of the bill provides for changes in the labeling requirements for foods under the Act as follows: a. Perishability Labeling
Section 9(a) requires "sell-date" labeling for perishable and semiperishable foods in packaged form. It defines a "perishable or semiperishable food" as a food, other than a raw agricultural commodity, which the Secretary determines which, as it agges, has a high risk of decay, deterioration, or significant loss of nut ional value.or ability. "Sell-date" is defined as the last date on which a perishable or semiperishable food can be sold for consumption without a high risk of spoilage or significant loss of nutritional value or palatability if stored by the consumer after that date for the period which the consumer would reasonably be expected to store the food.
Existing law provides the Secretary implicit authority to require selldate and food storage information on food labels in cases where the lack of this information may result in a food being adulterated or misbranded. Since the extent of this authority (and the manner in which this authority is to be exercised) is unclear under the Act, the bill proposes explicit statutory authority to facilitate the development of food perishability labeling requirements. b. Ingredient Labeling
Section 9 also requires the so-called mandatory ingredients in foods subject to a standard of identity to be listed on the label. It requires the listing of each coloring on the label of foods containing added artificial or natural colorings. It provides that individual spices and flavoring need not be specifically listed on the label unless the Secre0 gs
tary issues regulations to require their listing for the purpose of providing important health information to consumers. It authorizes
the Secretary to require the use of a symbol on the label of a food to signify the absence of any artificial flavor or color. In addition, it authorizes the Secretaryt require a declaration of the percentage of any specified ingredient (except a spice or flavor) on the label of a food, if he determines by reg ulationi that the ingredient has a significant bearing on the quality, 'nutrition, acceptability, or cost of- the food. Finally, it requires the listing of all food ingredients in the descendingg order of their predominance. c. Nutritional Labeling Information
Sect ion 9 further authorizes the Secretary to require the labels of packaged foods to bear nutritional information with respect to the food in order to provide health information to consumers. If these foods fail to bear this required nutritional information they would be deemed to be misbranded and subject to the enforcement provisions of the Act.
Under existing law, the Secretary may only require full nutritional information on the labels of special dietary foods, fortified and enriched foods, and foods for which nutritional claims are made by the processor or distributor. Nutritional labeling for other foods is voluntary.
(d. Nutritional Information in Advertising
Finally, section 9 requires the Secretary to notify the Federal Trade Commission of requirements for nutritional information in food labeling under section 403 (p) of the Act and to recommend to the Commission which, if any, of this nutritional information should be required by the Commission to be included in food advertising. It requires the Secretary to report annually to the appropriate committees of the House and Senate on any recommendations he makes to the Commission respecting the inclusion of nutritional information in food advertising.
This provision is intended to foster interagency coordination of regulatory requirements respecting nutritional claims-in food labeling, and advertising, and to help eliminate inconsistencies in these requirements which could mislead or confuse consumers.
9. IMPORT NOTICES
Section 10 of this bill requires persons who import food into the United States to file "import notices" identifying the imported food and its processor and containing other informaionwhich the Secretary may require for the protection of the public health. An import notice would1 also be required to contain assurances that good manufacturig practice regulations, applicable to a food, have been comp lied with by the foreign processor. The bill provides sanctions for failure to file these im port notices and requires the Secretary of the Treasury to refuse ad mission into the United States of any food for which an import notice has not been filed.
10. PRESUMPTION RESPECTING FOOD AND INTERSTATE COMMERCE
Section 11 of the bill provides a rebuttable presumption that the connection with interstate commerce, required for Federal jurisdiction, exists- with respect to a food in any action to enforce the requirements of the food provisions of the Act.
Presently, food inspectors must collect documentation of the interstate shipment of a food before the Secretary, can bring a seizure action against it. Experience has shown that virtually all fo( d is in interstate commerce under applicable judicial interpretations. Thus, the existing legal requirement; merely serve to cause unnecessary delay and impede agency actions against adulterated and misbranded foods.
Section 12 defines "food processor" to mean any person who owns or operates any establishment in which food is manufactured, prepared, treated, packed, labeled, stored, or otherwise handled or through which food is imported for commercial purposes. This definition also provides that the processing in an establishment of food for retail sale in that establishment does not make the owner or operator of that establishment a food processor for purposes of the Act. Section 12 also defines the term "process," when used to describe an activity involving food, as including the manufacturing, importing, preparing, testing, labeling, storing, and other handling of food.
Section 13 of the bill repeals the provisions of the Federal Food, Drug, and Cosmetic Act pertaining to adulterated margarine and to the sale and offering for sale of margarine not meeting special requirements under the Act.
13. ALCOHOLIC BEVERAGES
Section 14 of the bill amends the definition of "food" under the Federal Food, Drug, and Cosmetic Act to specifically include distilled spirits, wines, and malt beverages.
UNIVERSITY OF FLORIDA 3 1262 09119 2459